Trial Outcomes & Findings for Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke (NCT NCT03872401)
NCT ID: NCT03872401
Last Updated: 2026-06-25
Results Overview
All deaths and individual components were adjudicated by an independent external clinical events committee (CEC), using standardized definitions. The number of participants who experienced CHD death, MI, or ischemic stroke, whichever occurred first, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
12301 participants
Primary outcome timeframe
From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months
Results posted on
2026-06-25
Participant Flow
Participants were enrolled at 745 research centers in North America, Europe, Asia Pacific, and Latin America between June 2019 and July 2025.
Participants were randomized in a 1:1 ratio to receive either evolocumab 140 mg subcutaneously (SC) or placebo every two weeks (Q2W) via self-administration for a duration of approximately 6 years. A total of 12,301 participants were enrolled; however, data from 44 participants were excluded from all results analyses. Participant Flow data are therefore presented for a total of 12,257 participants in Full analysis set (FAS).
Participant milestones
| Measure |
Placebo Q2W
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Overall Study
STARTED
|
6128
|
6129
|
|
Overall Study
COMPLETED
|
5985
|
5999
|
|
Overall Study
NOT COMPLETED
|
143
|
130
|
Reasons for withdrawal
| Measure |
Placebo Q2W
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Overall Study
Withdrawal of consent from trial
|
104
|
93
|
|
Overall Study
Lost to Follow-up
|
24
|
19
|
|
Overall Study
Administrative reasons
|
15
|
16
|
|
Overall Study
Various reasons
|
0
|
2
|
Baseline Characteristics
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
Baseline characteristics by cohort
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
Total
n=12257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 6.9 • n=20 Participants
|
65.5 years
STANDARD_DEVIATION 6.9 • n=20 Participants
|
65.4 years
STANDARD_DEVIATION 6.9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
2595 Participants
n=20 Participants
|
2619 Participants
n=20 Participants
|
5214 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
3533 Participants
n=20 Participants
|
3510 Participants
n=20 Participants
|
7043 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1016 Participants
n=20 Participants
|
1017 Participants
n=20 Participants
|
2033 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5110 Participants
n=20 Participants
|
5110 Participants
n=20 Participants
|
10220 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
28 Participants
n=20 Participants
|
25 Participants
n=20 Participants
|
53 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
243 Participants
n=20 Participants
|
245 Participants
n=20 Participants
|
488 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
123 Participants
n=20 Participants
|
115 Participants
n=20 Participants
|
238 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
5693 Participants
n=20 Participants
|
5708 Participants
n=20 Participants
|
11401 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
65 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) monthsPopulation: FAS included all randomized participants. All participants were analyzed according to their randomized treatment assignment.
All deaths and individual components were adjudicated by an independent external clinical events committee (CEC), using standardized definitions. The number of participants who experienced CHD death, MI, or ischemic stroke, whichever occurred first, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Outcome measures
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Number of Participants Who Experienced Coronary Heart Disease (CHD) Death, Myocardial Infarction (MI), or Ischemic Stroke, Whichever Occurred First
|
443 Participants
|
336 Participants
|
PRIMARY outcome
Timeframe: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) monthsPopulation: FAS included all randomized participants. All participants were analyzed according to their randomized treatment assignment.
All deaths and individual components were adjudicated by an independent external CEC, using standardized definitions. The number of participants who experienced CHD death, MI, ischemic stroke, or any ischemia-driven arterial revascularization, whichever occurred first, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Outcome measures
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Number of Participants Who Experienced CHD Death, MI, Ischemic Stroke, or Any Ischemia-driven Arterial Revascularization, Whichever Occurred First
|
907 Participants
|
747 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) monthsPopulation: FAS included all randomized participants. All participants were analyzed according to their randomized treatment assignment.
All deaths and individual components were adjudicated by an independent external CEC, using standardized definitions. The number of participants who experienced MI, ischemic stroke, or any ischemia-driven arterial revascularization, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Outcome measures
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Number of Participants Who Experienced MI, Ischemic Stroke, or Any Ischemia-driven Arterial Revascularization
|
834 Participants
|
674 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) monthsPopulation: FAS included all randomized participants. All participants were analyzed according to their randomized treatment assignment.
All deaths and individual components were adjudicated by an independent external CEC, using standardized definitions. The number of participants who experienced CHD death, MI, or any ischemia-driven arterial revascularization, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Outcome measures
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Number of Participants Who Experienced CHD Death, MI, or Any Ischemia-driven Arterial Revascularization
|
819 Participants
|
664 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) monthsPopulation: FAS included all randomized participants. All participants were analyzed according to their randomized treatment assignment.
All deaths and individual components were adjudicated by an independent external CEC, using standardized definitions. The number of participants who experienced cardiovascular death, MI, or ischemic stroke, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Outcome measures
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Number of Participants Who Experienced Cardiovascular Death, MI, or Ischemic Stroke
|
503 Participants
|
374 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) monthsPopulation: FAS included all randomized participants. All participants were analyzed according to their randomized treatment assignment.
All deaths and individual components were adjudicated by an independent external CEC, using standardized definitions. The number of participants who experienced CHD death or MI, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Outcome measures
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Number of Participants Who Experienced CHD Death or MI
|
313 Participants
|
232 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) monthsPopulation: FAS included all randomized participants. All participants were analyzed according to their randomized treatment assignment.
All deaths and individual components were adjudicated by an independent external CEC, using standardized definitions. The number of participants who experienced MI, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Outcome measures
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Number of Participants Who Experienced MI
|
229 Participants
|
149 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) monthsPopulation: FAS included all randomized participants. All participants were analyzed according to their randomized treatment assignment.
All deaths and individual components were adjudicated by an independent external CEC, using standardized definitions. The number of participants who experienced ischemia-driven arterial revascularization, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Outcome measures
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Number of Participants Who Experienced Any Ischemia-driven Arterial Revascularization
|
699 Participants
|
561 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) monthsPopulation: FAS included all randomized participants. All participants were analyzed according to their randomized treatment assignment.
All deaths and individual components were adjudicated by an independent external CEC, using standardized definitions. The number of participants who experienced CHD death, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Outcome measures
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Number of Participants Who Experienced CHD Death
|
117 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) monthsPopulation: FAS included all randomized participants. All participants were analyzed according to their randomized treatment assignment.
All deaths and individual components were adjudicated by an independent external CEC, using standardized definitions. The number of participants who experienced cardiovascular death, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Outcome measures
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Number of Participants Who Experienced Cardiovascular Death
|
195 Participants
|
156 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) monthsPopulation: FAS included all randomized participants. All participants were analyzed according to their randomized treatment assignment.
All deaths and individual components were adjudicated by an independent external CEC, using standardized definitions. The number of participants who died due to any cause, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Outcome measures
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Number of Participants Who Died Due to Any Cause
|
539 Participants
|
434 Participants
|
SECONDARY outcome
Timeframe: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) monthsPopulation: FAS included all randomized participants. All participants were analyzed according to their randomized treatment assignment.
All deaths and individual components were adjudicated by an independent external CEC, using standardized definitions. The number of participants who experienced ischemic stroke, among participants at high cardiovascular risk without prior MI or stroke and were receiving optimized lipid lowering therapy was analyzed.
Outcome measures
| Measure |
Placebo Q2W
n=6128 Participants
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6129 Participants
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Number of Participants Who Experienced Ischemic Stroke
|
144 Participants
|
115 Participants
|
Adverse Events
Placebo Q2W
Serious events: 1772 serious events
Other events: 35 other events
Deaths: 539 deaths
Evolocumab 140 mg Q2W
Serious events: 1726 serious events
Other events: 55 other events
Deaths: 434 deaths
Serious adverse events
| Measure |
Placebo Q2W
n=6122 participants at risk
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6125 participants at risk
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.13%
8/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Latent autoimmune diabetes in adults
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Mineral deficiency
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Obesity
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Starvation ketoacidosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated myositis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Ligamentitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.16%
10/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.28%
17/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Lateral patellar compression syndrome
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.36%
22/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.20%
12/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Cold type haemolytic anaemia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Hyperchromic anaemia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.15%
9/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.10%
6/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Angina pectoris
|
1.6%
100/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
1.4%
83/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Angina unstable
|
1.6%
96/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
1.7%
102/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.26%
16/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.39%
24/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Arrhythmia
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Arrhythmic storm
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.20%
12/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
76/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
1.1%
68/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Atrial flutter
|
0.28%
17/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.21%
13/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Atrial tachycardia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Atrial thrombosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Atrioventricular block
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.18%
11/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.23%
14/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Atrioventricular node dysfunction
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Bradycardia
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardiac arrest
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardiac asthma
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardiac failure
|
1.0%
63/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.70%
43/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardiac failure acute
|
0.13%
8/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.31%
19/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.25%
15/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.34%
21/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.34%
21/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.39%
24/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardiac perforation
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardiac tamponade
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Chronic coronary syndrome
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Chronotropic incompetence
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Coronary artery disease
|
1.6%
101/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
1.3%
81/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Coronary artery perforation
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.36%
22/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.29%
18/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Dilated cardiomyopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Heart failure with midrange ejection fraction
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Heart failure with preserved ejection fraction
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.15%
9/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Heart failure with reduced ejection fraction
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Left ventricular failure
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Myocardial infarction
|
0.15%
9/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.11%
7/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.41%
25/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.34%
21/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Myocarditis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Palpitations
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Pericardial effusion
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Pericarditis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.18%
11/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.26%
16/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Subclavian coronary steal syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Tachycardia
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Endocrine disorders
Thyroid mass
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Congenital, familial and genetic disorders
Congenital aortic valve stenosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Congenital, familial and genetic disorders
Congenital heart valve disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Congenital, familial and genetic disorders
Diverticulitis Meckel's
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Congenital, familial and genetic disorders
Fallot's tetralogy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Congenital, familial and genetic disorders
Foramen magnum stenosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Congenital, familial and genetic disorders
Laryngocele
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Congenital, familial and genetic disorders
Venous angioma of brain
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Ear and labyrinth disorders
Otosclerosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Endocrine disorders
Goitre
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Endocrine disorders
Hyperthyroidism
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Endocrine disorders
Thyroiditis chronic
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Age-related macular degeneration
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Amaurosis fugax
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Cataract
|
0.13%
8/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.15%
9/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Choroiditis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Glaucoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Iridocyclitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Macular hole
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Non-proliferative retinopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Retinal artery occlusion
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Retinal detachment
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Uveitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Visual acuity reduced
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Eye disorders
Vitreous haemorrhage
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.11%
7/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.10%
6/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Anal fissure haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Anal fistula
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Anorectal polyp
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Aortoenteric fistula
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Ascites
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Bile acid malabsorption
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Coeliac artery stenosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Colitis
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Constipation
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Diverticulum
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Duodenal polyp
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Duodenitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Dysphagia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Enteritis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Faecaloma
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Food poisoning
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastric ischaemia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastritis
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.15%
9/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastrointestinal mucosa hyperaemia
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Haematochezia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.16%
10/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.20%
12/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Internal hernia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Intestinal angina
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Intestinal metaplasia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Mesenteric arterial occlusion
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Mesenteric artery embolism
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Necrotising oesophagitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Omental infarction
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.18%
11/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.16%
10/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Stomach mass
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Tongue polyp
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.16%
10/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Volvulus
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Gastrointestinal disorders
Vomiting
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Asthenia
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Chest discomfort
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Chest pain
|
0.47%
29/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.46%
28/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Complication associated with device
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Drug intolerance
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Drug withdrawal syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Fatigue
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Granuloma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Hernia
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Hyperthermia malignant
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Hypothermia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Incarcerated hernia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Malaise
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Mass
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Metaplasia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Non-cardiac chest pain
|
0.23%
14/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.29%
18/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Oedema
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Oedema peripheral
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Pain
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Prosthetic cardiac valve regurgitation
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Pyrexia
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Stent-graft endoleak
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Vascular stent occlusion
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Vascular stent stenosis
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.10%
6/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
General disorders
Vascular stent thrombosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Acute cholecystitis necrotic
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Biliary colic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Biliary cyst
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Cholangiectasis acquired
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.18%
11/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.20%
12/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.33%
20/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
15/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.21%
13/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Jaundice
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Liver injury
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Hepatobiliary disorders
Post cholecystectomy syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Immune system disorders
Amyloidosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Immune system disorders
Anaphylactic reaction
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Immune system disorders
Anaphylactic shock
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Immune system disorders
Drug hypersensitivity
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Immune system disorders
Eosinophilic granulomatosis with polyangiitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Immune system disorders
Sarcoidosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Abdominal sepsis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Abdominal wall abscess
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Abscess
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Abscess bacterial
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Actinomycotic pulmonary infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Adenoviral encephalitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Aerococcus urinae infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Anal abscess
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Appendicitis
|
0.20%
12/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.23%
14/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Appendicitis perforated
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Bacteraemia
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Bacterial infection
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Bacterial sepsis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Bronchitis
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Bursitis infective staphylococcal
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
COVID-19
|
0.60%
37/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.36%
22/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.4%
86/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
1.3%
82/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Campylobacter bacteraemia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Cellulitis
|
0.23%
14/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.29%
18/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Cholecystitis infective
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Chronic sinusitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Clostridium difficile infection
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Corneal abscess
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Cystitis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Device related infection
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Diabetic foot infection
|
0.13%
8/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Diverticulitis
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.23%
14/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Emphysematous cystitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Empyema
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Endocarditis
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Endocarditis bacterial
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Endophthalmitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Erysipelas
|
0.15%
9/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.15%
9/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Fournier's gangrene
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Fungal oesophagitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Gangrene
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.15%
9/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Gastroenteritis
|
0.16%
10/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.15%
9/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Gastrointestinal microorganism overgrowth
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Groin infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Haemorrhagic fever with renal syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Helicobacter duodenal ulcer
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Hepatitis E
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Infected bite
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Infected skin ulcer
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Infection
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Infective aneurysm
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Infective exacerbation of asthma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Infective periostitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Influenza
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.11%
7/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Kidney infection
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Laryngopharyngitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Localised infection
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Mediastinitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Medical device site infection
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Meningitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Mycoplasma infection
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Necrotising fasciitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Nosocomial infection
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Orchitis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Osteomyelitis
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.15%
9/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Osteomyelitis acute
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Osteomyelitis bacterial
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Otitis externa
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Otitis media
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Otitis media bacterial
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Paronychia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Penile infection
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pericarditis infective
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Periodontitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Peritonitis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pilonidal disease
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pneumonia
|
1.0%
64/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
1.2%
72/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pneumonia aspiration
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pneumonia bacterial
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.11%
7/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pneumonia influenzal
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pneumonia moraxella
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pneumonia necrotising
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pneumonia viral
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Post procedural infection
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Post procedural pneumonia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Postoperative abscess
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Postoperative wound infection
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pulmonary histoplasmosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pulmonary sepsis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pyelitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pyelonephritis
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.13%
8/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pyelonephritis acute
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Rectal abscess
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Renal abscess
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Respiratory tract infection
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Salpingo-oophoritis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Scrotal cellulitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Sepsis
|
0.25%
15/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.21%
13/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Sepsis associated acute kidney injury
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Sepsis syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Septic embolus
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Septic endocarditis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Septic shock
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Severe acute respiratory syndrome
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Sinusitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Skin infection
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Soft tissue infection
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Spinal cord abscess
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Streptococcal infection
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Superinfection
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Syphilis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Tooth abscess
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Tuberculosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Tularaemia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Urinary tract infection
|
0.33%
20/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.24%
15/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Urosepsis
|
0.20%
12/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.24%
15/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Vascular device infection
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Vestibular neuronitis
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Wound infection
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Wound infection pseudomonas
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Abdominal wall wound
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.16%
10/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.18%
11/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Aortic restenosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Complications of bone marrow transplant
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Coronary vascular graft stenosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Deep vein thrombosis postoperative
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Failed back surgery syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Fall
|
0.13%
8/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.13%
8/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.11%
7/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.18%
11/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.13%
8/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.15%
9/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Intervertebral disc injury
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Open globe injury
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Periprocedural myocardial infarction
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.13%
8/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Splenosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.13%
8/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Traumatic arthrosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Traumatic subarachnoid haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Ulnar nerve injury
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Vascular graft stenosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Wound
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Blood pressure abnormal
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Blood pressure increased
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Electrocardiogram QRS complex shortened
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Escherichia test positive
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Inflammatory marker increased
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Liver function test increased
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Transaminases increased
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Troponin increased
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Investigations
Weight increased
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.26%
16/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.13%
8/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.16%
10/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.11%
7/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Oligoarthritis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteitis deformans
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
69/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
1.6%
96/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Rapidly progressive osteoarthritis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.11%
7/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.16%
10/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.10%
6/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Spinal retrolisthesis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.15%
9/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.11%
7/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Spinal synovial cyst
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Thoracic spinal stenosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.18%
11/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma malignant
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma, low grade
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.13%
8/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.20%
12/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign anorectal neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct adenocarcinoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma recurrent
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder adenocarcinoma stage unspecified
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.13%
8/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage 0, with cancer in situ
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage I, with cancer in situ
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage II
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.10%
6/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage II
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.13%
8/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.10%
6/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage I
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage II
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondrosarcoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chordoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic leukaemia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia stage 0
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.13%
8/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage II
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage IV
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage I
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage I
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage II
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage III
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage IV
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal submucosal tumour
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hormone receptor positive breast cancer
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory pseudotumour
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer recurrent
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage IV
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma metastatic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant anorectal neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage 0
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mediastinum neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Natural killer-cell leukaemia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm of appendix
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nervous system neoplasm benign
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the lung
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the lung metastatic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage I
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma stage 0
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal papilloma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian clear cell carcinoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian endometrioid carcinoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary cystadenoma lymphomatosum
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pelvic neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral T-cell lymphoma unspecified
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell leukaemia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prolactin-producing pituitary tumour
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.42%
26/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.67%
41/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage 0
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage IV
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pseudomyxoma peritonei
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage I
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage III
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage IV
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin squamous cell carcinoma recurrent
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine neuroendocrine tumour
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vagina
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vulva
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular germ cell tumour
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular neoplasm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma recurrent
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour thrombosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer metastatic
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Warty dyskeratoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Amnesia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Amputation stump pain
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Aphasia
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Balance disorder
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Basal ganglia stroke
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.39%
24/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.39%
24/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Central nervous system lesion
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebellar atherosclerosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebral circulatory failure
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebral haematoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebral infarction
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebral microangiopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.15%
9/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.10%
6/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Cognitive disorder
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Coma acidotic
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Dementia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Diabetic encephalopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Dizziness
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Dysarthria
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Encephalopathy
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Epilepsy
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Frontotemporal dementia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Headache
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Hemiparesis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Hydrocephalus
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Hyperglycaemic seizure
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Lacunar stroke
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Intracranial haematoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Intracranial hypotension
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Ischaemic stroke
|
0.13%
8/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Loss of consciousness
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Migraine
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Morton's neuralgia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Myasthenia gravis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Myasthenia gravis crisis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Neuralgia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Neurodegenerative disorder
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Neurological symptom
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Occipital lobe stroke
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Parkinson's disease
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Post stroke epilepsy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Presyncope
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Radiculopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Sciatica
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Seizure
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Spinal claudication
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Spinal cord compression
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Spinal meningeal cyst
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Spinal stroke
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Status migrainosus
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Stroke in evolution
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Subdural hygroma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Superior sagittal sinus thrombosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Syncope
|
0.31%
19/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.26%
16/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Temporal lobe epilepsy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Transient global amnesia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.39%
24/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.39%
24/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Transverse sinus thrombosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Tremor
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Vertebrobasilar stroke
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Wernicke's encephalopathy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Pregnancy, puerperium and perinatal conditions
Cephalhaematoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Product Issues
Device breakage
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Product Issues
Device dislocation
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Product Issues
Device leakage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Product Issues
Device loosening
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Product Issues
Device malfunction
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Product Issues
Device occlusion
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Product Issues
Device pacing issue
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Alcohol abuse
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Confusional state
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Delirium
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Depression
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Drug use disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Hallucination, visual
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Major depression
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Mental status changes
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Psychiatric disorders
Suicide attempt
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.59%
36/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.44%
27/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Bladder tamponade
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Calculus bladder
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Calculus urinary
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.13%
8/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Dysuria
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
End stage renal disease
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Glomerulonephritis acute
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Glomerulonephritis membranoproliferative
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Haematuria
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Intercapillary glomerulosclerosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.15%
9/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.13%
8/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Renal artery thrombosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Renal atrophy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Renal failure
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Renal hypertension
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Renal impairment
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.13%
8/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Renal pseudoaneurysm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Urinary retention
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Renal and urinary disorders
Urogenital fistula
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.21%
13/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.26%
16/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Cystocele
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.16%
10/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.15%
9/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.23%
14/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.26%
16/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory disease
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.21%
13/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperoxia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity pneumonitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal cyst
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal polyp
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.16%
10/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.10%
6/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fibrosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.44%
27/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.33%
20/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.13%
8/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic haemorrhage
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Cellulite
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.28%
17/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.11%
7/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Diabetic wound
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.08%
5/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Arrhythmia prophylaxis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Colostomy closure
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Hysterectomy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Limb operation
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Peripheral artery angioplasty
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Surgical and medical procedures
Wrist surgery
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Accelerated hypertension
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Angiopathy
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Aortic aneurysm
|
0.15%
9/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.10%
6/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Aortic disorder
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Aortic intramural haematoma
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Aortic stenosis
|
0.18%
11/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.28%
17/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Arterial insufficiency
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Arterial occlusive disease
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Arterial stenosis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Arteriosclerosis
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Bleeding varicose vein
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Brachiocephalic arteriosclerosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Brachiocephalic artery stenosis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Circulatory collapse
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Deep vein thrombosis
|
0.31%
19/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.16%
10/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Dry gangrene
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Embolism venous
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Essential hypertension
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Extremity necrosis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Femoral artery aneurysm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Giant cell arteritis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Haematoma
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Hypertension
|
0.67%
41/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.38%
23/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Hypertensive crisis
|
0.23%
14/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.26%
16/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Hypertensive urgency
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Hypotension
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Hypovolaemic shock
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Iliac artery arteriosclerosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Iliac artery occlusion
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Iliac artery restenosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Iliac artery stenosis
|
0.11%
7/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Infarction
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Intermittent claudication
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.13%
8/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Ischaemia
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Lymphatic fistula
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Lymphorrhoea
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Necrosis ischaemic
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Orthostatic hypotension
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.4%
86/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
1.2%
75/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Peripheral embolism
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.03%
2/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.16%
10/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.15%
9/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.15%
9/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.28%
17/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.08%
5/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Peripheral ischaemia
|
0.25%
15/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.38%
23/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.07%
4/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Post thrombotic syndrome
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Secondary hypertension
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Subclavian artery occlusion
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.07%
4/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Varicose vein
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.05%
3/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Vascular insufficiency
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Vascular occlusion
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Vascular stenosis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Vasculitis
|
0.02%
1/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.00%
0/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.02%
1/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
Other adverse events
| Measure |
Placebo Q2W
n=6122 participants at risk
Participants received placebo SC injection Q2W.
|
Evolocumab 140 mg Q2W
n=6125 participants at risk
Participants received 140 mg evolocumab by subcutaneous injection Q2W.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.05%
3/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.13%
8/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.13%
8/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.11%
7/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.29%
18/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.49%
30/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Nervous system disorders
Headache
|
0.10%
6/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.18%
11/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.03%
2/6122 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
0.15%
9/6125 • All-cause mortality: From enrollment to last confirmed survival status date; median (min, max) time on trial was 55.2 (0.0, 72.7) months. Serious adverse events (AEs) and other AEs: From first dose of trial drug to last dose + 30 days or end of trial; median (min, max) time on trial was 51.5 (0.0, 72.4) months.
All-cause mortality is reported for all participants enrolled in the trial and included in the results analyses. AEs are reported for the safety analysis set, which included all randomized participants who received at least 1 dose of investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER