Trial Outcomes & Findings for Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (NCT NCT02545049)
NCT ID: NCT02545049
Last Updated: 2022-04-15
Results Overview
Number of participants with the first occurrence of the primary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were reported as descriptive result.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
7352 participants
Primary outcome timeframe
From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.
Results posted on
2022-04-15
Participant Flow
Study was conducted at multiple centers in 48 countries/regions between 17-Sep-2015 (first participant first visit) and 02-Feb-2021 (last participant last visit).
Overall, 19381 participants were screened. Of them,11944 participants were screening failures and 7437 participants were randomized. 85 participants were prospectively excluded from the analyses due to critical GCP violations resulting in 7352 in full analysis set. 7341 participants received study treatment. 1 participant was assigned to placebo but received finerenone.
Participant milestones
| Measure |
Finerenone
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
|
Placebo
Participants received matching placebo once daily in addition to standard of care therapy
|
|---|---|---|
|
Overall Study
STARTED
|
3723
|
3714
|
|
Overall Study
Treated
|
3683
|
3658
|
|
Overall Study
Included in FAS
|
3686
|
3666
|
|
Overall Study
COMPLETED
|
3681
|
3653
|
|
Overall Study
NOT COMPLETED
|
42
|
61
|
Reasons for withdrawal
| Measure |
Finerenone
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
|
Placebo
Participants received matching placebo once daily in addition to standard of care therapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
GCP violations
|
37
|
48
|
Baseline Characteristics
Participants in FAS with evaluable data
Baseline characteristics by cohort
| Measure |
Finerenone
n=3686 Participants
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
|
Placebo
n=3666 Participants
Participants received matching placebo once daily in addition to standard of care therapy
|
Total
n=7352 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.13 Years
STANDARD_DEVIATION 9.67 • n=3686 Participants
|
64.13 Years
STANDARD_DEVIATION 10.00 • n=3666 Participants
|
64.13 Years
STANDARD_DEVIATION 9.83 • n=7352 Participants
|
|
Sex: Female, Male
Female
|
1158 Participants
n=3686 Participants
|
1089 Participants
n=3666 Participants
|
2247 Participants
n=7352 Participants
|
|
Sex: Female, Male
Male
|
2528 Participants
n=3686 Participants
|
2577 Participants
n=3666 Participants
|
5105 Participants
n=7352 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
618 Participants
n=3686 Participants
|
603 Participants
n=3666 Participants
|
1221 Participants
n=7352 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3058 Participants
n=3686 Participants
|
3057 Participants
n=3666 Participants
|
6115 Participants
n=7352 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=3686 Participants
|
6 Participants
n=3666 Participants
|
16 Participants
n=7352 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
73 Participants
n=3686 Participants
|
70 Participants
n=3666 Participants
|
143 Participants
n=7352 Participants
|
|
Race (NIH/OMB)
Asian
|
715 Participants
n=3686 Participants
|
739 Participants
n=3666 Participants
|
1454 Participants
n=7352 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
17 Participants
n=3686 Participants
|
14 Participants
n=3666 Participants
|
31 Participants
n=7352 Participants
|
|
Race (NIH/OMB)
Black or African American
|
113 Participants
n=3686 Participants
|
145 Participants
n=3666 Participants
|
258 Participants
n=7352 Participants
|
|
Race (NIH/OMB)
White
|
2672 Participants
n=3686 Participants
|
2605 Participants
n=3666 Participants
|
5277 Participants
n=7352 Participants
|
|
Race (NIH/OMB)
More than one race
|
87 Participants
n=3686 Participants
|
86 Participants
n=3666 Participants
|
173 Participants
n=7352 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=3686 Participants
|
7 Participants
n=3666 Participants
|
16 Participants
n=7352 Participants
|
|
Urinary albumin-to-creatinine ratio (UACR)
|
302.36 milligram/gram (mg/g)
n=3686 Participants • Participants in FAS with evaluable data
|
315.06 milligram/gram (mg/g)
n=3664 Participants • Participants in FAS with evaluable data
|
308.18 milligram/gram (mg/g)
n=7350 Participants • Participants in FAS with evaluable data
|
|
Estimated glomerular filtration rate (eGFR)
|
67.62 mL/min/1.73m^2
STANDARD_DEVIATION 21.65 • n=3686 Participants • Participants in FAS with evaluable data
|
67.99 mL/min/1.73m^2
STANDARD_DEVIATION 21.74 • n=3665 Participants • Participants in FAS with evaluable data
|
67.80 mL/min/1.73m^2
STANDARD_DEVIATION 21.69 • n=7351 Participants • Participants in FAS with evaluable data
|
PRIMARY outcome
Timeframe: From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.Population: Full analysis set (FAS)
Number of participants with the first occurrence of the primary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were reported as descriptive result.
Outcome measures
| Measure |
Finerenone
n=3686 Participants
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
|
Placebo
n=3666 Participants
Participants received matching placebo once daily in addition to standard of care therapy
|
|---|---|---|
|
The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure.
|
458 Participants
|
519 Participants
|
SECONDARY outcome
Timeframe: From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.Number of participants with first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death were reported as descriptive result.
Outcome measures
| Measure |
Finerenone
n=3686 Participants
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
|
Placebo
n=3666 Participants
Participants received matching placebo once daily in addition to standard of care therapy
|
|---|---|---|
|
The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death.
|
350 Participants
|
395 Participants
|
SECONDARY outcome
Timeframe: From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average study duration of 41 monthsPopulation: Full analysis set
Number of participants with first occurrence of a hospitalization event were reported as descriptive result.
Outcome measures
| Measure |
Finerenone
n=3686 Participants
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
|
Placebo
n=3666 Participants
Participants received matching placebo once daily in addition to standard of care therapy
|
|---|---|---|
|
All-cause Hospitalization
|
1573 Participants
|
1605 Participants
|
SECONDARY outcome
Timeframe: From randomization up until death due to any cause, or censoring at the end of the study, with an average study duration of 41 monthsPopulation: Full analysis set
Number of participants with death due to any cause were reported as descriptive result. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table.
Outcome measures
| Measure |
Finerenone
n=3686 Participants
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
|
Placebo
n=3666 Participants
Participants received matching placebo once daily in addition to standard of care therapy
|
|---|---|---|
|
All-cause Mortality
|
333 Participants
|
370 Participants
|
SECONDARY outcome
Timeframe: From baseline up until Month 4Population: Subjects in full analysis set with measurements available within the time window of Month 4
First morning void urine samples were collected to evaluate the urinary albumin-to-creatinine ratio (UACR). Month 4 was the visit closest to day 120 within a time window of 120 ± 30 days after randomization. If no measurements were available in this time window, the participant was excluded from this analysis. Ratio of UACR at Month 4 to UACR at baseline is reported as the change.
Outcome measures
| Measure |
Finerenone
n=3521 Participants
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
|
Placebo
n=3476 Participants
Participants received matching placebo once daily in addition to standard of care therapy
|
|---|---|---|
|
Change in Urinary Albumin-to-creatine Ratio (UCAR) From Baseline to Month 4
|
0.624 Ratio
Interval 0.606 to 0.642
|
0.922 Ratio
Interval 0.896 to 0.949
|
SECONDARY outcome
Timeframe: From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 monthsPopulation: Full analysis set
Number of participants with first occurrence of the renal composite outcome, onset of kidney failure, a sustained decrease in eGFR of ≥57% from baseline over at least 4 weeks, or renal death were reported as descriptive result.
Outcome measures
| Measure |
Finerenone
n=3686 Participants
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
|
Placebo
n=3666 Participants
Participants received matching placebo once daily in addition to standard of care therapy
|
|---|---|---|
|
The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of ≥57% From Baseline Over at Least 4 Weeks, or Renal Death
|
108 Participants
|
139 Participants
|
Adverse Events
Finerenone
Serious events: 1158 serious events
Other events: 1797 other events
Deaths: 339 deaths
Placebo
Serious events: 1215 serious events
Other events: 1717 other events
Deaths: 383 deaths
Serious adverse events
| Measure |
Finerenone
n=3683 participants at risk
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
|
Placebo
n=3658 participants at risk
Participants received matching placebo once daily in addition to standard of care therapy
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.49%
18/3683 • Number of events 21 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.41%
15/3658 • Number of events 15 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Hilar lymphadenopathy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Hypereosinophilic syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Acquired haemophilia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Angina pectoris
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Angina unstable
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Arrhythmia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Atrial fibrillation
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Bradycardia
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Cardiac arrest
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Cardiac failure
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.27%
10/3658 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Cardiac failure acute
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Cardiomyopathy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Coronary artery disease
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Extrasystoles
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Palpitations
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Pericarditis
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Sinoatrial block
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Cardiac disorders
Cardiac dysfunction
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Congenital, familial and genetic disorders
Arnold-Chiari malformation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Congenital, familial and genetic disorders
Anomaly of middle ear congenital
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Ear and labyrinth disorders
Vertigo
|
0.19%
7/3683 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Ear and labyrinth disorders
Vestibular ataxia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Endocrine disorders
Goitre
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Endocrine disorders
Hypothyroidism
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Endocrine disorders
Primary hyperaldosteronism
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Endocrine disorders
Toxic nodular goitre
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Cataract
|
0.41%
15/3683 • Number of events 18 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.30%
11/3658 • Number of events 16 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Cataract diabetic
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Dermatochalasis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Diabetic eye disease
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Diabetic retinopathy
|
0.30%
11/3683 • Number of events 21 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.19%
7/3658 • Number of events 8 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Diplopia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Extraocular muscle paresis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Eye haemorrhage
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Glaucoma
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Macular oedema
|
0.03%
1/3683 • Number of events 12 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Ophthalmoplegia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Retinal detachment
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Retinal haemorrhage
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Retinopathy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Retinopathy proliferative
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Vision blurred
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Vitreous haemorrhage
|
0.43%
16/3683 • Number of events 23 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.19%
7/3658 • Number of events 8 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Macular hole
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Eyelid cyst
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Age-related macular degeneration
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Ulcerative keratitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Ocular ischaemic syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Eye disorders
Macular fibrosis
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Anal fistula
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Ascites
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Colitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Constipation
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.19%
7/3683 • Number of events 8 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Enteritis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Food poisoning
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastritis
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.19%
7/3683 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.25%
9/3658 • Number of events 12 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.25%
9/3658 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.19%
7/3658 • Number of events 11 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Melaena
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.14%
5/3683 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.33%
12/3683 • Number of events 16 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.05%
2/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Volvulus
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Vomiting
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastric dysplasia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Oesophageal dysplasia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Subileus
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.38%
14/3683 • Number of events 16 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.30%
11/3658 • Number of events 13 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Oesophageal polyp
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Internal hernia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.03%
1/3683 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Intestinal mass
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Abdominal symptom
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Pancreatic duct stenosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Omental infarction
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Abdominal hernia perforation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Dental cyst
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Asthenia
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Chest pain
|
0.49%
18/3683 • Number of events 18 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.55%
20/3658 • Number of events 22 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Death
|
0.22%
8/3683 • Number of events 8 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Generalised oedema
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Impaired healing
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Malaise
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Oedema
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Oedema peripheral
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.25%
9/3658 • Number of events 21 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Pain
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Pyrexia
|
0.16%
6/3683 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Sudden death
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Peripheral swelling
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
General physical health deterioration
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.22%
8/3658 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Oedema due to cardiac disease
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Haemorrhagic cyst
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Adhesion
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Polyp
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Drug intolerance
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Complication associated with device
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Hanging
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Biliary colic
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Biliary fistula
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Cholangitis
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
7/3683 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.24%
9/3683 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.19%
7/3658 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.19%
7/3658 • Number of events 9 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Fatty liver alcoholic
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Liver disorder
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Cholecystocholangitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Hepatobiliary disorders
Primary biliary cholangitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Immune system disorders
Anaphylactic shock
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Abdominal wall abscess
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Abscess
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Acute sinusitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Anorectal cellulitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Appendicitis
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Arteriosclerotic gangrene
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Aspergilloma
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Bacteraemia
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Bronchitis
|
0.19%
7/3683 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.25%
9/3658 • Number of events 9 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Cellulitis
|
1.1%
40/3683 • Number of events 46 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.77%
28/3658 • Number of events 29 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Cellulitis gangrenous
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Chronic hepatitis C
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Chronic sinusitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Corneal abscess
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Cystitis
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Dengue fever
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Diabetic gangrene
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Diverticulitis
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Endocarditis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Erysipelas
|
0.27%
10/3683 • Number of events 12 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.41%
15/3658 • Number of events 21 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Fournier's gangrene
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Furuncle
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Gangrene
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Gastroenteritis
|
0.30%
11/3683 • Number of events 12 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.41%
15/3658 • Number of events 15 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Gastroenteritis viral
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Herpes zoster
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
HIV infection
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Infected skin ulcer
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Infection
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Infectious mononucleosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Infective myositis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Influenza
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Localised infection
|
0.24%
9/3683 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Mastoiditis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Meningitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Necrotising fasciitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Orchitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Osteomyelitis
|
0.33%
12/3683 • Number of events 16 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.36%
13/3658 • Number of events 13 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Osteomyelitis acute
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Otitis externa
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Otitis media
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Peritonitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pharyngitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pilonidal cyst
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pneumonia
|
2.0%
73/3683 • Number of events 77 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
3.1%
113/3658 • Number of events 121 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pneumonia influenzal
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pneumonia viral
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Postoperative wound infection
|
0.19%
7/3683 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Prostatic abscess
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pulmonary mycosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pyelitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pyelonephritis
|
0.24%
9/3683 • Number of events 9 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pyelonephritis acute
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Salpingitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Sepsis
|
0.43%
16/3683 • Number of events 16 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.55%
20/3658 • Number of events 21 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Septic shock
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Sialoadenitis
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Subacute endocarditis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Subcutaneous abscess
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Tuberculosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Urinary tract infection
|
0.76%
28/3683 • Number of events 33 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
1.1%
39/3658 • Number of events 40 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Viral infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Wound infection
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Urosepsis
|
0.33%
12/3683 • Number of events 15 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.36%
13/3658 • Number of events 13 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Anal abscess
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Sinobronchitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Urinary tract infection fungal
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Abscess limb
|
0.24%
9/3683 • Number of events 12 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Febrile infection
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Arthritis bacterial
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Abscess neck
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Bacterial sepsis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Stenotrophomonas sepsis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Abdominal infection
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Infective tenosynovitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Acute hepatitis B
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Intervertebral discitis
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Diabetic foot infection
|
0.19%
7/3683 • Number of events 9 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Bacterial infection
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pneumonia bacterial
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.19%
7/3658 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Arthritis infective
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Genitourinary tract infection
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Tracheobronchitis viral
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Bronchitis bacterial
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Soft tissue infection
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Respiratory tract infection
|
0.16%
6/3683 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Cholecystitis infective
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Otitis externa bacterial
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Wound infection bacterial
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Emphysematous pyelonephritis
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Infectious pleural effusion
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Herpes zoster meningoencephalitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Medical device site infection
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Intestinal sepsis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Spinal cord abscess
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Necrotising soft tissue infection
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Infected bite
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Vascular graft infection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
COVID-19
|
0.46%
17/3683 • Number of events 17 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.60%
22/3658 • Number of events 22 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.24%
9/3683 • Number of events 9 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.30%
11/3658 • Number of events 11 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Accident
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.16%
6/3683 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Fall
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.22%
8/3683 • Number of events 8 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.22%
8/3658 • Number of events 8 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Foreign body aspiration
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.14%
5/3683 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Injury
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.14%
5/3683 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.11%
4/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Intervertebral disc injury
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.05%
2/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Vascular anastomosis aneurysm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Cerebral hyperperfusion syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Wound contamination
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Dental restoration failure
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Ocular procedural complication
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Injury, poisoning and procedural complications
Reproductive tract procedural complication
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Arthroscopy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Biopsy bladder
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Biopsy kidney
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Biopsy liver
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Biopsy prostate
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Blood creatinine increased
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Blood glucose increased
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Blood potassium decreased
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Blood potassium increased
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Blood pressure increased
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
C-reactive protein increased
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Colonoscopy
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Colonoscopy normal
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Computerised tomogram
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Electrocardiogram abnormal
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Endoscopy
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Glomerular filtration rate decreased
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Haematocrit decreased
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Blood urine present
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
International normalised ratio increased
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Weight decreased
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Angiogram cerebral
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Sleep study
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Blood pressure orthostatic decreased
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Troponin increased
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Cardiac function test abnormal
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Angiogram
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Investigation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Endobronchial ultrasound
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Gastrointestinal stoma output increased
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Liver function test increased
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Cancer staging
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
Angiocardiogram
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Investigations
SARS-CoV-2 test negative
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.22%
8/3683 • Number of events 8 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.27%
10/3658 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.54%
20/3683 • Number of events 24 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.68%
25/3658 • Number of events 31 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.73%
27/3683 • Number of events 34 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.46%
17/3658 • Number of events 20 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.22%
8/3658 • Number of events 8 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Gout
|
0.05%
2/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.62%
23/3683 • Number of events 24 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.30%
11/3658 • Number of events 11 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.62%
23/3683 • Number of events 25 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.46%
17/3683 • Number of events 20 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.77%
28/3658 • Number of events 31 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.16%
6/3683 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.19%
7/3658 • Number of events 9 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Obesity
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Mineral metabolism disorder
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Periarthritis calcarea
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.90%
33/3683 • Number of events 45 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.68%
25/3658 • Number of events 33 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.49%
18/3683 • Number of events 20 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.36%
13/3658 • Number of events 16 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.16%
6/3683 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
8/3683 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.60%
22/3683 • Number of events 23 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.25%
9/3658 • Number of events 11 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Plantar fascial fibromatosis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 13 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Resorption bone increased
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.22%
8/3683 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.25%
9/3658 • Number of events 9 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue haemorrhage
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Inclusion body myositis
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Diastasis recti abdominis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Tendon discomfort
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Vertebral lateral recess stenosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Immobilisation syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of prostate
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.30%
11/3683 • Number of events 13 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.08%
3/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.38%
14/3683 • Number of events 15 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.25%
9/3658 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Enchondromatosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioblastoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory papilloma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.03%
1/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.08%
3/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ear neoplasm malignant
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid neoplasm
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.19%
7/3683 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.22%
8/3658 • Number of events 8 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.27%
10/3683 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.66%
24/3658 • Number of events 24 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign anorectal neoplasm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastrointestinal neoplasm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female reproductive neoplasm
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.08%
3/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour invasion
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of spleen
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epithelioid mesothelioma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.08%
3/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive papillary breast carcinoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary cystadenoma lymphomatosum
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Triple negative breast cancer
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma recurrent
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the parotid gland
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Altered state of consciousness
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Amnesia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Aphasia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Cerebral infarction
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Coma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Dementia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Diabetic ketoacidotic hyperglycaemic coma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.30%
11/3683 • Number of events 13 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.19%
7/3658 • Number of events 9 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Dizziness
|
0.19%
7/3683 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.22%
8/3658 • Number of events 8 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Dizziness postural
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Dysarthria
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Dyskinesia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Epilepsy
|
0.05%
2/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Facial paralysis
|
0.11%
4/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Headache
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Hemiparesis
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Hypoaesthesia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Lethargy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Loss of consciousness
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Memory impairment
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Moyamoya disease
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Myelopathy
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Neuralgia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Polyneuropathy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Presyncope
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Radiculopathy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Sciatica
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Seizure
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Sensory disturbance
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Spinal cord compression
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Syncope
|
0.38%
14/3683 • Number of events 14 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.44%
16/3658 • Number of events 16 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Tension headache
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Ulnar neuritis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Vascular headache
|
0.05%
2/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Vertigo CNS origin
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Balance disorder
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Dysstasia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Lacunar infarction
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Cognitive disorder
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Ischaemic stroke
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Partial seizures
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Mononeuropathy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Amputation stump pain
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Hyperglycaemic unconsciousness
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Peripheral nerve paresis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Posthaemorrhagic hydrocephalus
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Central nervous system vasculitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Psychiatric disorders
Anxiety
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Psychiatric disorders
Completed suicide
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Psychiatric disorders
Confusional state
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Psychiatric disorders
Delusional disorder, unspecified type
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Psychiatric disorders
Depression
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Psychiatric disorders
Mental status changes
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Psychiatric disorders
Bipolar disorder
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Psychiatric disorders
Major depression
|
0.03%
1/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Psychiatric disorders
Suicide threat
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Albuminuria
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Calculus bladder
|
0.08%
3/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Calculus urinary
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Haematuria
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.33%
12/3683 • Number of events 13 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.22%
8/3658 • Number of events 11 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Nephropathy
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Renal colic
|
0.08%
3/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Renal failure
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Urinary retention
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Bladder neck sclerosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.27%
10/3683 • Number of events 12 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.71%
26/3658 • Number of events 38 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Renal impairment
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
38/3683 • Number of events 39 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
1.3%
46/3658 • Number of events 48 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.16%
6/3683 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Renal and urinary disorders
Subacute kidney injury
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.33%
12/3683 • Number of events 12 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.27%
10/3658 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Breast mass
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Breast necrosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Prostatism
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Reproductive system and breast disorders
Scrotal dermatitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.33%
12/3683 • Number of events 12 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.25%
9/3658 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.60%
22/3683 • Number of events 24 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.44%
16/3658 • Number of events 26 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.24%
9/3683 • Number of events 11 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.25%
9/3658 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.19%
7/3658 • Number of events 10 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.16%
6/3683 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.30%
11/3658 • Number of events 11 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.16%
6/3683 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.25%
9/3658 • Number of events 12 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.14%
5/3683 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mass
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal disorder
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hepatic hydrothorax
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar lung disease
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Lung perforation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Small airways disease
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.03%
1/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.33%
12/3683 • Number of events 12 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.41%
15/3658 • Number of events 20 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Neuropathic ulcer
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Necrobiosis lipoidica diabeticorum
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.62%
23/3683 • Number of events 24 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.49%
18/3658 • Number of events 22 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Angiokeratoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Reactive perforating collagenosis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Skin and subcutaneous tissue disorders
Diabetic cheiroarthropathy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Abscess drainage
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Bladder calculus removal
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Bladder neck resection
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.19%
7/3658 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Circumcision
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Finger amputation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Foot amputation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Hysterectomy
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Incisional hernia repair
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Insertion of ambulatory peritoneal catheter
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Intensive care
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Internal fixation of fracture
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.22%
8/3683 • Number of events 8 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.25%
9/3658 • Number of events 9 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Leg amputation
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Lipoma excision
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Lung lobectomy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Nasal polypectomy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Parathyroidectomy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Parotidectomy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Radical hysterectomy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Radioactive iodine therapy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Removal of foreign body from larynx
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Renal cyst excision
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Renal stone removal
|
0.05%
2/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Roux loop conversion
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Scar excision
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Skin ulcer excision
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Spinal decompression
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Toe amputation
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Uterine polypectomy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Vitrectomy
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Ureteral stent insertion
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Radical prostatectomy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Diabetes mellitus management
|
0.05%
2/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Preoperative care
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Transurethral bladder resection
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Neurolysis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Polypectomy
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Caecum operation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Peripheral artery angioplasty
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Peripheral nerve decompression
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Proctocolectomy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Brachytherapy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Limb operation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Aortic surgery
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Bone operation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Chemotherapy
|
0.05%
2/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Colectomy
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Eye operation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Eyelid operation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Gastrectomy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Gastric bypass
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Hydrocele operation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Lithotripsy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Retinal operation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Varicose vein operation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Skin graft
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Spinal operation
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Drug therapy
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Vascular stent insertion
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Cataract operation
|
0.19%
7/3683 • Number of events 9 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Rectocele repair
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Neurosurgery
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Pancreatic stent placement
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Breast conserving surgery
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Transcatheter aortic valve implantation
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Metabolic surgery
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Atrial appendage closure
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Cheilectomy
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Biliary catheter removal
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Renal disorder prophylaxis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Ocular stem cell transplant
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Surgical and medical procedures
Drug delivery device placement
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Aortic aneurysm
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Aortic dissection
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Aortic stenosis
|
0.14%
5/3683 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Aortitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Circulatory collapse
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Giant cell arteritis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Haematoma
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Hypertension
|
0.33%
12/3683 • Number of events 12 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.60%
22/3658 • Number of events 28 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Hypertensive crisis
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 6 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Hypotension
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Orthostatic hypotension
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Peripheral ischaemia
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Phlebitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Shock
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Subclavian steal syndrome
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Systolic hypertension
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Thrombophlebitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Thrombosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Varicose ulceration
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Varicose vein
|
0.03%
1/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Vasculitis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Post thrombotic syndrome
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Labile hypertension
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Dry gangrene
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Deep vein thrombosis
|
0.08%
3/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.14%
5/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.05%
2/3658 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Hypertensive emergency
|
0.05%
2/3683 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.08%
3/3658 • Number of events 3 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Hypertensive urgency
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.11%
4/3658 • Number of events 5 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Extremity necrosis
|
0.11%
4/3683 • Number of events 4 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Peripheral embolism
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.05%
2/3683 • Number of events 2 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.16%
6/3658 • Number of events 7 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Subclavian artery occlusion
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.00%
0/3658 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.03%
1/3683 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Peripheral artery aneurysm rupture
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Product Issues
Device malfunction
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Product Issues
Device loosening
|
0.00%
0/3683 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
0.03%
1/3658 • Number of events 1 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
Other adverse events
| Measure |
Finerenone
n=3683 participants at risk
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
|
Placebo
n=3658 participants at risk
Participants received matching placebo once daily in addition to standard of care therapy
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
210/3683 • Number of events 227 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
5.4%
199/3658 • Number of events 215 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
185/3683 • Number of events 213 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
4.7%
171/3658 • Number of events 192 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
235/3683 • Number of events 283 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
6.0%
220/3658 • Number of events 271 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
General disorders
Oedema peripheral
|
5.3%
197/3683 • Number of events 227 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
7.6%
278/3658 • Number of events 343 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Bronchitis
|
5.2%
191/3683 • Number of events 238 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
4.8%
176/3658 • Number of events 214 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
318/3683 • Number of events 537 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
8.9%
327/3658 • Number of events 497 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
225/3683 • Number of events 351 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
5.5%
203/3658 • Number of events 310 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
246/3683 • Number of events 335 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
6.0%
220/3658 • Number of events 313 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.7%
322/3683 • Number of events 470 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
4.3%
159/3658 • Number of events 219 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
296/3683 • Number of events 379 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
7.1%
260/3658 • Number of events 337 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
260/3683 • Number of events 288 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
6.9%
252/3658 • Number of events 287 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Nervous system disorders
Dizziness
|
5.2%
190/3683 • Number of events 218 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
4.5%
166/3658 • Number of events 184 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
|
Vascular disorders
Hypertension
|
5.4%
199/3683 • Number of events 241 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
8.1%
296/3658 • Number of events 347 • After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months.
Adverse events are reported for the safety analysis set (SAF) that comprised all randomized participants who took at least 1 dose of study drug (except those with critical GCP violations). Adverse events for all-cause mortality are reported for the Full analysis set (FAS) that comprised all randomized participants (except those with critical GCP violations) and considers all deaths after randomization, including those after the end of study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER