Trial Outcomes & Findings for Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial) (NCT NCT03521934)
NCT ID: NCT03521934
Last Updated: 2022-10-28
Results Overview
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1222 participants
Primary outcome timeframe
Up to 21.9 months
Results posted on
2022-10-28
Participant Flow
Participants took part in the study at 306 investigative sites in North America, Latin America, Western Europe, Eastern Europe, and the Rest of the World from 15 June 2018 to 05 June 2020.
Participants with a diagnosis of Type 2 Diabetes post Worsening Heart Failure were enrolled equally in 1 of 2 treatment groups, sotagliflozin or placebo.
Participant milestones
| Measure |
Sotagliflozin
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
608
|
614
|
|
Overall Study
Randomized and Treated
|
605
|
611
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
608
|
614
|
Reasons for withdrawal
| Measure |
Sotagliflozin
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
|---|---|---|
|
Overall Study
Death
|
65
|
73
|
|
Overall Study
Withdrawal by Subject
|
18
|
23
|
|
Overall Study
Site Terminated by Sponsor
|
39
|
35
|
|
Overall Study
Study Terminated by Sponsor
|
483
|
477
|
|
Overall Study
Reason not Specified
|
3
|
6
|
Baseline Characteristics
Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
Baseline characteristics by cohort
| Measure |
Sotagliflozin
n=608 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
n=614 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
Total
n=1222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
69.3 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
198 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
412 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
410 Participants
n=5 Participants
|
400 Participants
n=7 Participants
|
810 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
163 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
438 Participants
n=5 Participants
|
455 Participants
n=7 Participants
|
893 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
567 Participants
n=5 Participants
|
572 Participants
n=7 Participants
|
1139 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 21.9 monthsPopulation: ITT population includes all randomized participants.
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=608 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
n=614 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
|---|---|---|
|
Number of Total Occurrences of Cardiovascular (CV) Death, Hospitalizations for Heart Failure (HHF) and Urgent Visits for Heart Failure (HF)
|
51 events per 100-person years
|
76.3 events per 100-person years
|
SECONDARY outcome
Timeframe: Up to 21.9 monthsPopulation: ITT population includes all randomized participants.
Combined endpoint of the total occurrences (first and potentially subsequent) of HHF and urgent HF visits after randomization. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=608 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
n=614 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
|---|---|---|
|
Total Number of Occurrences of HHF and Urgent HF Visits
|
40.4 events per 100-person years
|
63.9 events per 100-person years
|
SECONDARY outcome
Timeframe: Up to 21.9 monthsPopulation: ITT population includes all randomized participants.
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=608 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
n=614 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
|---|---|---|
|
Total Number of Deaths From Cardiovascular Causes
|
10.6 events per 100-person years
|
12.5 events per 100-person years
|
SECONDARY outcome
Timeframe: Up to 21.9 monthsPopulation: ITT population includes all randomized participants.
Combined endpoint of the total number of occurrences (first and potentially subsequent) of CV death, HHF, non-fatal stroke, and non-fatal myocardial infarction after randomisation. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=608 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
n=614 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
|---|---|---|
|
Total Number of Occurrences of CV Death, HHF, Non-fatal Myocardial Infarction and Non-fatal Stroke
|
51.4 events per 100-person years
|
71.0 events per 100-person years
|
SECONDARY outcome
Timeframe: Up to 21.9 monthsPopulation: ITT population includes all randomized participants.
Combined endpoint of the total number of occurrences (first and potentially subsequent) after randomisation of HHF, urgent HF visits, CV Death and HF while hospitalised. Events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=608 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
n=614 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
|---|---|---|
|
Total Number of Occurrences of HHF, Urgent HF Visit, CV Death, and HF While Hospitalized
|
54.7 events per 100-person years
|
80.6 events per 100-person years
|
SECONDARY outcome
Timeframe: Up to 21.9 monthsPopulation: ITT population includes all randomized participants.
Number of events that occurred during the study were calculated as the total number of events per 100 person-years of follow-up.
Outcome measures
| Measure |
Sotagliflozin
n=608 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
n=614 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
|---|---|---|
|
Total Number of Deaths From Any Cause
|
13.5 events per 100-person years
|
16.3 events per 100-person years
|
SECONDARY outcome
Timeframe: Baseline to Month 4Population: ITT population includes all randomized participants.
KCCQ-12 is a 12 question questionnaire, participants completed questionnaire about how heart failure affected their life over the past 2 weeks. The scale has 4 domains: symptom frequency, physical limitation, social limitations and quality of life for a total possible transformed score of 0 to 100 where 100 denotes the highest health status. A positive change from baseline indicates improvement. An analysis of covariance (ANCOVA) model was used for analysis.
Outcome measures
| Measure |
Sotagliflozin
n=608 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
n=614 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
|---|---|---|
|
Change From Baseline in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Scores at Month 4
|
17.7 score on a scale
Standard Error 0.41
|
13.6 score on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline up to 21.9 monthsPopulation: ITT population includes all randomized participants.
eGFR is a test for renal function. A blood sample was collected and was sent to a central laboratory. eGFR was calculated by the Modification of Diet in Renal Disease (MDRD) equation reported as milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2). A mixed model for repeated measures (MMRM) was used for analysis.
Outcome measures
| Measure |
Sotagliflozin
n=608 Participants
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
n=614 Participants
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
|---|---|---|
|
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
|
-0.34 mL/min/1.73 m^2
Standard Error 1.33
|
-0.18 mL/min/1.73 m^2
Standard Error 1.33
|
Adverse Events
Sotagliflozin
Serious events: 235 serious events
Other events: 101 other events
Deaths: 65 deaths
Placebo
Serious events: 251 serious events
Other events: 90 other events
Deaths: 76 deaths
Serious adverse events
| Measure |
Sotagliflozin
n=605 participants at risk
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
n=611 participants at risk
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
|---|---|---|
|
Vascular disorders
Aortic rupture
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Arteriosclerosis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Circulatory collapse
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Hypertension
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Hypotension
|
0.99%
6/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.82%
5/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Peripheral artery occlusion
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Peripheral ischaemia
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Surgical and medical procedures
Cardiac rehabilitation therapy
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Surgical and medical procedures
Cardiac resynchronisation therapy
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Surgical and medical procedures
Therapeutic procedure
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Asthenia
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Cardiac death
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Chest pain
|
0.50%
3/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Death
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.65%
4/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Fatigue
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Generalised oedema
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Nodule
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Non-cardiac chest pain
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.49%
3/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Oedema peripheral
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Pyrexia
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.49%
3/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Sudden cardiac death
|
1.2%
7/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
1.5%
9/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Sudden death
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Psychiatric disorders
Acute psychosis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Psychiatric disorders
Anxiety
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Psychiatric disorders
Depression
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.49%
3/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Psychiatric disorders
Drug abuse
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Psychiatric disorders
Psychotic disorder
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Psychiatric disorders
Suicidal ideation
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Fall
|
0.66%
4/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Investigations
Alanine aminotransferase increased
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Investigations
Biopsy prostate
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Investigations
Blood glucose increased
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Investigations
Catheterisation cardiac
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Investigations
Ejection fraction decreased
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Investigations
Liver function test increased
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Investigations
SARS-CoV-2 test positive
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Investigations
Transaminases increased
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Investigations
Transplant evaluation
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Acute left ventricular failure
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.66%
4/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.49%
3/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Angina pectoris
|
0.66%
4/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.49%
3/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Angina unstable
|
1.3%
8/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
8/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
1.3%
8/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Atrial flutter
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Atrioventricular block
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Cardiac arrest
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Cardiac failure
|
13.2%
80/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
19.8%
121/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Cardiac failure acute
|
2.0%
12/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
1.8%
11/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Cardiac failure chronic
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
1.3%
8/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Cardiac failure congestive
|
1.8%
11/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
2.6%
16/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Cardiogenic shock
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Coronary artery disease
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Coronary artery occlusion
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Mitral valve incompetence
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Myocardial infarction
|
0.99%
6/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
1.5%
9/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Pericarditis
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Right ventricular failure
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Sinoatrial block
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Sinus node dysfunction
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Ventricular fibrillation
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.66%
4/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.65%
4/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.83%
5/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.49%
3/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.50%
3/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.65%
4/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.49%
3/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.50%
3/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.98%
6/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.50%
3/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.49%
3/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
1.1%
7/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Cerebral haematoma
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.83%
5/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.49%
3/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Coma
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Dizziness
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Hemiparesis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Ischaemic stroke
|
1.5%
9/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
1.5%
9/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Myelopathy
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Postresuscitation encephalopathy
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Seizure
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Spinal cord ischaemia
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Spinal cord ischaemia Syncope
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
2.0%
12/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Eye disorders
Eye haemorrhage
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.49%
3/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Colitis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Constipation
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.65%
4/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Haematochezia
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Splenic artery aneurysm
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Ulcerative gastritis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.49%
3/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
11/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
2.6%
16/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Renal and urinary disorders
Calculus urinary
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.50%
3/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.98%
6/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Renal and urinary disorders
Haematuria
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Renal and urinary disorders
Renal failure
|
0.50%
3/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.98%
6/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.49%
3/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Hepatobiliary disorders
Liver disorder
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Hepatobiliary disorders
Liver injury
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Product Issues
Device malfunction
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Product Issues
Lead dislodgement
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
3/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.50%
3/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.65%
4/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Gout
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.65%
4/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Hyperinsulinaemic hypoglycaemia
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.65%
4/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
8/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.65%
4/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.65%
4/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Bronchitis
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
COVID-19
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Cellulitis
|
0.66%
4/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Clostridium difficile infection
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Endocarditis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Erysipelas
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Gangrene
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Gastroenteritis viral
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Infective thrombosis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Influenza
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Pharyngotonsillitis
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Pneumonia
|
3.1%
19/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
4.3%
26/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Pyelonephritis
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Pyelonephritis acute
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Respiratory tract infection
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.33%
2/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Sepsis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.65%
4/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Septic shock
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.65%
4/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Skin infection
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Soft tissue infection
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.17%
1/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.00%
0/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Urinary tract infection
|
0.33%
2/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.98%
6/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Urosepsis
|
0.50%
3/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Infections and infestations
Viral infection
|
0.00%
0/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
0.16%
1/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
Other adverse events
| Measure |
Sotagliflozin
n=605 participants at risk
Sotagliflozin 200 mg tablet once daily, with possible up-titration in the first 8 months to 400 mg, for up to 21.2 months.
|
Placebo
n=611 participants at risk
Matching placebo to sotagliflozin 200 mg once daily, with possible up-titration in the first 8 months to matching placebo to sotagliflozin 400 mg, for up to 21.6 months.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
5.5%
33/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
4.4%
27/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Cardiac disorders
Cardiac failure
|
6.8%
41/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
9.3%
57/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
36/605 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
2.9%
18/611 • First dose of study drug up to 10 days after the last dose of study drug (Up to 21.9 months)
Number of Deaths (All causes) is based on all randomized participants (n=608,614). Adverse Events are based on the Safety population that included all randomized participants who received at least one dose of study drug (n=605,611).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable subject matter.
- Publication restrictions are in place
Restriction type: OTHER