Trial Outcomes & Findings for Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation (NCT NCT03795298)
NCT ID: NCT03795298
Last Updated: 2025-09-18
Results Overview
Occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism events adjudicated by an Independent Clinical Event Committee
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1600 participants
Primary outcome timeframe
From randomization to 1095 days post randomization
Results posted on
2025-09-18
Participant Flow
1600 subjects were randomized from 11-Jun-2019 to 16-Jul-2021
803 subjects were randomized to the WATCHMAN FLX DEVICE and 797 subjects were randomized to the OAC Control group (ITT analysis set)
Participant milestones
| Measure |
Oral Anticoagulant (Control)
Catheter ablation for atrial ablation followed by market-approved OAC for the duration of the trial
|
WATCHMAN FLX DEVICE
Catheter ablation for atrial fibrillation followed by WATCHMAN FLX Device implant with market-approved OAC and aspirin until the 3-month visit followed by aspirin until at least the 12-month visit
|
|---|---|---|
|
Overall Study
STARTED
|
797
|
803
|
|
Overall Study
COMPLETED
|
679
|
714
|
|
Overall Study
NOT COMPLETED
|
118
|
89
|
Reasons for withdrawal
| Measure |
Oral Anticoagulant (Control)
Catheter ablation for atrial ablation followed by market-approved OAC for the duration of the trial
|
WATCHMAN FLX DEVICE
Catheter ablation for atrial fibrillation followed by WATCHMAN FLX Device implant with market-approved OAC and aspirin until the 3-month visit followed by aspirin until at least the 12-month visit
|
|---|---|---|
|
Overall Study
Death
|
34
|
29
|
|
Overall Study
Death > 1095 day (not included in endpoint analyses)
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
28
|
17
|
|
Overall Study
Physician Decision
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
43
|
28
|
|
Overall Study
Reason not reported
|
7
|
9
|
Baseline Characteristics
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
Baseline characteristics by cohort
| Measure |
Oral Anticoagulant (Control)
n=797 Participants
Catheter ablation for atrial ablation followed by market-approved OAC for the duration of the trial
|
WATCHMAN FLX DEVICE
n=803 Participants
Catheter ablation for atrial fibrillation followed by WATCHMAN FLX Device implant with market-approved OAC and aspirin until the 3-month visit followed by aspirin until at least the 12-month visit
|
Total
n=1600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.4 Years at time of Consent
STANDARD_DEVIATION 7.9 • n=5 Participants
|
69.7 Years at time of Consent
STANDARD_DEVIATION 7.4 • n=7 Participants
|
69.5 Years at time of Consent
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
533 Participants
n=5 Participants
|
520 Participants
n=7 Participants
|
1053 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
263 Participants
n=5 Participants
|
283 Participants
n=7 Participants
|
546 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Intersex
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, of African heritage
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
686 Participants
n=5 Participants
|
673 Participants
n=7 Participants
|
1359 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not disclosed
|
83 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
562 Participants
n=5 Participants
|
560 Participants
n=7 Participants
|
1122 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
61 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
100 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to 1095 days post randomizationPopulation: The primary analysis for the primary effectiveness endpoint was performed on an intent-to-treat basis, with all randomized subjects analyzed as part of their randomized group regardless of the actual treatment received.
Occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism events adjudicated by an Independent Clinical Event Committee
Outcome measures
| Measure |
Oral Anticoagulant (Control)
n=797 Participants
Catheter ablation for atrial ablation followed by market-approved OAC for the duration of the trial
|
WATCHMAN FLX DEVICE
n=803 Participants
Catheter ablation for atrial fibrillation followed by WATCHMAN FLX Device implant with market-approved OAC and aspirin until the 3-month visit followed by aspirin until at least the 12-month visit
|
|---|---|---|
|
Primary Effectiveness Endpoint: Stroke, All Cause Death, and Systemic Embolism
|
44 Participants
|
41 Participants
|
PRIMARY outcome
Timeframe: Non-procedural events are those occurring after 3 days, calculated from implant or attempted implant date for Device patients and from date of randomization for Control patientsPopulation: The primary analysis for the primary safety endpoint was performed on an intent-to-treat basis, with all randomized subjects analyzed as part of their randomized group regardless of the actual treatment received
Occurrence of non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding) events adjudicated by an Independent Clinical Event Committee
Outcome measures
| Measure |
Oral Anticoagulant (Control)
n=797 Participants
Catheter ablation for atrial ablation followed by market-approved OAC for the duration of the trial
|
WATCHMAN FLX DEVICE
n=803 Participants
Catheter ablation for atrial fibrillation followed by WATCHMAN FLX Device implant with market-approved OAC and aspirin until the 3-month visit followed by aspirin until at least the 12-month visit
|
|---|---|---|
|
Primary Safety Endpoint: Non-procedural Bleeding
|
137 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: From randomization to 1095 days post randomizationPopulation: The primary analysis for the secondary endpoint was performed on an intent-to-treat basis, with all randomized subjects analyzed as part of their randomized group regardless of the actual treatment received
Occurence of ISTH major bleeding (including procedural bleeding) events adjudicated by an Independent Clinical Event Committee
Outcome measures
| Measure |
Oral Anticoagulant (Control)
n=797 Participants
Catheter ablation for atrial ablation followed by market-approved OAC for the duration of the trial
|
WATCHMAN FLX DEVICE
n=803 Participants
Catheter ablation for atrial fibrillation followed by WATCHMAN FLX Device implant with market-approved OAC and aspirin until the 3-month visit followed by aspirin until at least the 12-month visit
|
|---|---|---|
|
ISTH Major Bleeding
|
38 Participants
|
30 Participants
|
Adverse Events
Oral Anticoagulant (Control)
Serious events: 797 serious events
Other events: 248 other events
Deaths: 35 deaths
WATCHMAN FLX DEVICE
Serious events: 803 serious events
Other events: 254 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
Oral Anticoagulant (Control)
n=797 participants at risk
Catheter ablation for atrial ablation followed by market-approved OAC for the duration of the trial
|
WATCHMAN FLX DEVICE
n=803 participants at risk
Catheter ablation for atrial fibrillation followed by WATCHMAN FLX Device implant with market-approved OAC and aspirin until the 3-month visit followed by aspirin until at least the 12-month visit
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Cerebral infarction
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Cerebral ischaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Cerebrovascular accident
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Anaemia
|
0.88%
7/797 • Number of events 7 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Acute myocardial infarction
|
0.88%
7/797 • Number of events 8 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.1%
9/803 • Number of events 9 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Angina pectoris
|
1.6%
13/797 • Number of events 13 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.2%
10/803 • Number of events 11 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Angina unstable
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Aortic valve disease
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Aortic valve stenosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Atrial fibrillation
|
15.7%
125/797 • Number of events 176 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
17.1%
137/803 • Number of events 186 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Atrial flutter
|
3.5%
28/797 • Number of events 29 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
4.4%
35/803 • Number of events 47 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Atrial tachycardia
|
1.1%
9/797 • Number of events 9 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.6%
13/803 • Number of events 13 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Atrial thrombosis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Atrioventricular block
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Bradyarrhythmia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Bradycardia
|
0.63%
5/797 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.75%
6/803 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiac arrest
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiac failure
|
1.8%
14/797 • Number of events 16 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
2.0%
16/803 • Number of events 18 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiac failure acute
|
0.63%
5/797 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.1%
9/803 • Number of events 9 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiac failure chronic
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiac failure congestive
|
0.88%
7/797 • Number of events 9 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.9%
15/803 • Number of events 17 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiac tamponade
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiogenic shock
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiomyopathy
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiovascular disorder
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Coronary artery disease
|
2.0%
16/797 • Number of events 18 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
2.1%
17/803 • Number of events 17 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Coronary artery stenosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Left ventricular failure
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Mitral valve disease mixed
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Mitral valve incompetence
|
0.88%
7/797 • Number of events 9 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Myocardial infarction
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Myocardial ischaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Myocarditis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Nodal rhythm
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Palpitations
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Pericardial effusion
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.75%
6/803 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.13%
1/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Pericarditis
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Sinus arrest
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Sinus bradycardia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Sinus node dysfunction
|
0.88%
7/797 • Number of events 7 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.00%
8/803 • Number of events 8 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.88%
7/797 • Number of events 8 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.50%
4/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Tachycardia
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Tachycardia induced cardiomyopathy
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.38%
3/797 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Ventricular fibrillation
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Ventricular tachycardia
|
0.88%
7/797 • Number of events 7 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.75%
6/803 • Number of events 7 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Ear and labyrinth disorders
Vertigo
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.50%
4/803 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Endocrine disorders
Hyperaldosteronism
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Cataract
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Diplopia
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Macular hole
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Macular oedema
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Ocular retrobulbar haemorrhage
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Retinal artery occlusion
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Retinal detachment
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Retinal tear
|
0.13%
1/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Vision blurred
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Abdominal pain
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Colitis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Diarrhoea
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Duodenal polyp
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Dysphagia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Enterocele
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastric disorder
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastric polyps
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastritis
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastritis alcoholic
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
13/797 • Number of events 14 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.87%
7/803 • Number of events 7 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Haematemesis
|
0.38%
3/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Ileus
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.75%
6/803 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Pancreatitis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.0%
8/797 • Number of events 9 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Retroperitoneal mass
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.13%
1/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.50%
4/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Vomiting
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Asthenia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Cardiac death
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Catheter site haematoma
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Catheter site haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Chest discomfort
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Chest pain
|
0.63%
5/797 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Cyst
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Death
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Device related thrombosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Drug intolerance
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Hernia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Impaired healing
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Medical device site haematoma
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Non-cardiac chest pain
|
1.4%
11/797 • Number of events 11 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.75%
6/803 • Number of events 8 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Pyrexia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Stent-graft endoleak
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Vascular stent stenosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Hepatobiliary disorders
Biliary colic
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Hepatobiliary disorders
Cholangitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Hepatobiliary disorders
Hepatic failure
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Hepatobiliary disorders
Pneumobilia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Immune system disorders
Kidney transplant rejection
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Abdominal abscess
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Abscess
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Abscess limb
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Appendicitis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Bacteraemia
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Bronchitis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Cellulitis
|
0.63%
5/797 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Clostridium difficile colitis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Corona virus infection
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.75%
6/803 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Device related infection
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Diverticulitis
|
0.38%
3/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Empyema
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Encephalitis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Erysipelas
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Gallbladder empyema
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Gangrene
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Gastroenteritis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Infection
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Influenza
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Lung infection
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Meningitis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Meningitis listeria
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Oesophageal candidiasis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Orchitis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Otitis externa
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Pneumococcal sepsis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Pneumonia
|
2.5%
20/797 • Number of events 25 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
3.5%
28/803 • Number of events 31 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Pyelonephritis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Pyelonephritis acute
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Sepsis
|
0.63%
5/797 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Septic shock
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Tracheobronchitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Urinary tract infection
|
0.75%
6/797 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.50%
4/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Urosepsis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Viral infection
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Vulval abscess
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Wound infection
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Accident
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Concussion
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Contusion
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Fracture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.13%
1/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Musculoskeletal procedural complication
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Procedural shock
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Investigations
Blood glucose increased
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Investigations
Heart rate increased
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Investigations
Lumbar puncture
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Investigations
Transaminases increased
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Investigations
Troponin increased
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.38%
3/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.4%
19/797 • Number of events 20 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.9%
15/803 • Number of events 18 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angioimmunoblastic T-cell lymphoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign cardiac neoplasm
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage I
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endocrine neoplasm
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Altered state of consciousness
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Aphasia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Ataxia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Balance disorder
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Brain injury
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Carotid artery stenosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Dementia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Dizziness
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Dizziness postural
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Encephalopathy
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Facial paralysis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Ischaemic stroke
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Leukoencephalopathy
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Migraine
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Myelopathy
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Presyncope
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Seizure
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Syncope
|
0.88%
7/797 • Number of events 8 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.1%
9/803 • Number of events 9 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Transient ischaemic attack
|
0.88%
7/797 • Number of events 7 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.4%
11/803 • Number of events 11 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Product Issues
Device dislocation
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Product Issues
Device failure
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Product Issues
Device lead damage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Product Issues
Device leakage
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Product Issues
Device loosening
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Product Issues
Lead dislodgement
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Psychiatric disorders
Cardiovascular somatic symptom disorder
|
0.13%
1/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Psychiatric disorders
Depression
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Psychiatric disorders
Mental status changes
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
13/797 • Number of events 14 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.9%
15/803 • Number of events 19 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Bladder mass
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
End stage renal disease
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Haematuria
|
1.3%
10/797 • Number of events 11 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.87%
7/803 • Number of events 7 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Nocturia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Renal failure
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Renal impairment
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Urogenital haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Reproductive system and breast disorders
Penile haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Reproductive system and breast disorders
Prostatitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
8/797 • Number of events 8 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.87%
7/803 • Number of events 8 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Asthma-chronic obstructive pulmonary disease overlap syndrome
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.75%
6/803 • Number of events 11 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.63%
5/797 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.50%
4/803 • Number of events 7 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pleural thickening
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.00%
8/803 • Number of events 8 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.63%
5/797 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Surgical and medical procedures
Bladder neoplasm surgery
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Surgical and medical procedures
Medical device change
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Surgical and medical procedures
Tricuspid valve replacement
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Air embolism
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Aortic stenosis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Arteriosclerosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Deep vein thrombosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Embolism
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Haematoma
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Haemodynamic instability
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Hypertension
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 7 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Hypertensive emergency
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Hypotension
|
1.0%
8/797 • Number of events 8 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.50%
4/803 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Hypovolaemic shock
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Intermittent claudication
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Orthostatic hypotension
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.50%
4/803 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Peripheral artery stenosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Peripheral ischaemia
|
0.25%
2/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Peripheral vascular disorder
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Peripheral venous disease
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Shock
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Venous thrombosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
Other adverse events
| Measure |
Oral Anticoagulant (Control)
n=797 participants at risk
Catheter ablation for atrial ablation followed by market-approved OAC for the duration of the trial
|
WATCHMAN FLX DEVICE
n=803 participants at risk
Catheter ablation for atrial fibrillation followed by WATCHMAN FLX Device implant with market-approved OAC and aspirin until the 3-month visit followed by aspirin until at least the 12-month visit
|
|---|---|---|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Psychiatric disorders
Suicide attempt
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Acute kidney injury
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.50%
4/803 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Haematuria
|
2.1%
17/797 • Number of events 19 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.4%
11/803 • Number of events 11 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Renal cyst
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Renal impairment
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Urinary incontinence
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.4%
35/797 • Number of events 41 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.2%
10/803 • Number of events 11 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.75%
6/803 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary vein stenosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Skin and subcutaneous tissue disorders
Vascular purpura
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Surgical and medical procedures
Atrial appendage closure
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Aneurysm
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Aortic stenosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Haematoma
|
1.5%
12/797 • Number of events 12 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Haemorrhage
|
0.63%
5/797 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Hypertension
|
0.13%
1/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Hypotension
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Orthostatic hypotension
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Vascular disorders
Venous haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Catheter site bruise
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Catheter site haematoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Catheter site haemorrhage
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Chest discomfort
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.50%
4/803 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Chest pain
|
0.75%
6/797 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Device related thrombosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.4%
11/803 • Number of events 12 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Fatigue
|
0.25%
2/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Anaemia
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Angina pectoris
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Angina unstable
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Arrhythmia
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Atrial fibrillation
|
6.8%
54/797 • Number of events 62 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
8.8%
71/803 • Number of events 88 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Atrial flutter
|
2.6%
21/797 • Number of events 24 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
2.1%
17/803 • Number of events 20 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Atrial septal defect acquired
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Bradycardia
|
0.75%
6/797 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Bundle branch block right
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiac failure
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiac failure acute
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiac failure congestive
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Coronary artery disease
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Left ventricular failure
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Myocardial ischaemia
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Pericardial effusion
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.4%
11/803 • Number of events 11 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Pericarditis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Sinus bradycardia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Sinus tachycardia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Cardiac disorders
Ventricular tachycardia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Endocrine disorders
Hyperthyroidism
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Cataract
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Conjunctival haemorrhage
|
0.75%
6/797 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Eye irritation
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Eyelid haematoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Keratitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Eye disorders
Visual impairment
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Colitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Dyspepsia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.13%
1/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Haematochezia
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.63%
5/797 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Melaena
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Gait disturbance
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Hernia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Influenza like illness
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Mass
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Medical device site haematoma
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Non-cardiac chest pain
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
General disorders
Oedema peripheral
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Immune system disorders
Drug hypersensitivity
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Bronchitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Cellulitis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Corona virus infection
|
0.75%
6/797 • Number of events 6 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
1.00%
8/803 • Number of events 8 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Cystitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Diverticulitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Erysipelas
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Fungal skin infection
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Herpes virus infection
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Infected bite
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Influenza
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Lung infection
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Onychomycosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Paronychia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Pneumonia
|
0.38%
3/797 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Pneumonia bacterial
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Respiratory tract infection
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Upper respiratory tract infection
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Urinary tract infection
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Contusion
|
0.88%
7/797 • Number of events 7 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.87%
7/803 • Number of events 7 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Fall
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Carotid artery stenosis
|
0.13%
1/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Cerebral infarction
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Cerebrovascular accident
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Cognitive disorder
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Dementia
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Diabetic neuropathy
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Dizziness
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Dysarthria
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Facial paralysis
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Headache
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Ischaemic stroke
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Memory impairment
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Neuropathy peripheral
|
0.25%
2/797 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Phrenic nerve paralysis
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Presyncope
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.25%
2/803 • Number of events 2 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Retinal migraine
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Seizure
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Syncope
|
0.50%
4/797 • Number of events 4 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.62%
5/803 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Transient ischaemic attack
|
0.63%
5/797 • Number of events 5 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.37%
3/803 • Number of events 3 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Product Issues
Device dislocation
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Product Issues
Device electrical impedance issue
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Product Issues
Device failure
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.12%
1/803 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Product Issues
Device leakage
|
0.00%
0/797 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.87%
7/803 • Number of events 7 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
|
Product Issues
Lead dislodgement
|
0.13%
1/797 • Number of events 1 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
0.00%
0/803 • Study events reported below include all events that were reported through study completion, up to 3 years. Note: primary endpoint analyses only included deaths that occurred between randomization and 1095 days post-randomization
Site reported
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER