Trial Outcomes & Findings for Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (NCT NCT02928497)
NCT ID: NCT02928497
Last Updated: 2026-08-25
Results Overview
The primary safety endpoint is the 7-day combined rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention measured only in the device arm, therefore the control is "0".
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
481 participants
Primary outcome timeframe
7 days
Results posted on
2026-08-25
Participant Flow
The enrollment was prematurely terminated on October 15, 2020, with 481 randomized patients. As discussed in the ASAP-TOO Update Meeting held on 16-September-2020 with FDA (Q150603-S001-A005), termination of enrollment was not due to safety concerns nor related to a protocol update, but rather due to significant delays in enrollment, the COVID-19 pandemic and its impact on investigational centers' ability to conduct research activities.
Participant milestones
| Measure |
Control
Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.
|
WATCHMAN (Device)
WATCHMAN LAAC Device implant including modified post-implant drug regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
161
|
320
|
|
Overall Study
COMPLETED
|
53
|
176
|
|
Overall Study
NOT COMPLETED
|
108
|
144
|
Reasons for withdrawal
| Measure |
Control
Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.
|
WATCHMAN (Device)
WATCHMAN LAAC Device implant including modified post-implant drug regimen.
|
|---|---|---|
|
Overall Study
Death
|
45
|
105
|
|
Overall Study
Physician Decision
|
14
|
7
|
|
Overall Study
Withdrawal by Subject
|
39
|
25
|
|
Overall Study
Lost to Follow-up
|
10
|
7
|
Baseline Characteristics
Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation
Baseline characteristics by cohort
| Measure |
WATCHMAN (Device)
n=320 Participants
WATCHMAN LAAC Device implant including modified post-implant drug regimen.
|
Control
n=161 Participants
Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.
|
Total
n=481 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.2 Years
STANDARD_DEVIATION 7.9 • n=31 Participants
|
74.7 Years
STANDARD_DEVIATION 8.1 • n=49 Participants
|
75.0 Years
STANDARD_DEVIATION 8.0 • n=80 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=31 Participants
|
62 Participants
n=49 Participants
|
188 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
194 Participants
n=31 Participants
|
99 Participants
n=49 Participants
|
293 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Ethnicity and Race · American Indian or Alaska native
|
1 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Ethnicity and Race · Asian
|
7 Participants
n=31 Participants
|
4 Participants
n=49 Participants
|
11 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Ethnicity and Race · Black, of African heritage
|
14 Participants
n=31 Participants
|
7 Participants
n=49 Participants
|
21 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Ethnicity and Race · Caucasian
|
270 Participants
n=31 Participants
|
138 Participants
n=49 Participants
|
408 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Ethnicity and Race · Hispanic or Latino
|
4 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
5 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Ethnicity and Race · Native Hawaiian or other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Ethnicity and Race · Other
|
3 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
6 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Ethnicity and Race · Not disclosed
|
21 Participants
n=31 Participants
|
8 Participants
n=49 Participants
|
29 Participants
n=80 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=31 Participants
|
2 Participants
n=49 Participants
|
6 Participants
n=80 Participants
|
|
Region of Enrollment
Canada
|
8 Participants
n=31 Participants
|
5 Participants
n=49 Participants
|
13 Participants
n=80 Participants
|
|
Region of Enrollment
Czechia
|
9 Participants
n=31 Participants
|
3 Participants
n=49 Participants
|
12 Participants
n=80 Participants
|
|
Region of Enrollment
Denmark
|
10 Participants
n=31 Participants
|
5 Participants
n=49 Participants
|
15 Participants
n=80 Participants
|
|
Region of Enrollment
Germany
|
18 Participants
n=31 Participants
|
12 Participants
n=49 Participants
|
30 Participants
n=80 Participants
|
|
Region of Enrollment
Italy
|
2 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
3 Participants
n=80 Participants
|
|
Region of Enrollment
United Kingdom
|
25 Participants
n=31 Participants
|
13 Participants
n=49 Participants
|
38 Participants
n=80 Participants
|
|
Region of Enrollment
United States
|
242 Participants
n=31 Participants
|
119 Participants
n=49 Participants
|
361 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: The primary safety endpoint was tested against the performance goal in the device arm only as described in the outcome measure description.
The primary safety endpoint is the 7-day combined rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention measured only in the device arm, therefore the control is "0".
Outcome measures
| Measure |
WATCHMAN (Device)
n=313 Participants
WATCHMAN LAAC Device implant including modified post-implant drug regimen.
|
Control
Single Antiplatelet Therapy or No Therapy (Control): Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.
|
|---|---|---|
|
Primary 7-Day Device/Procedural Safety Endpoint
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: ITT
Occurrence of ischemic stroke and systemic embolism adjudicated by and Independent Clinical Event Committee.
Outcome measures
| Measure |
WATCHMAN (Device)
n=320 Participants
WATCHMAN LAAC Device implant including modified post-implant drug regimen.
|
Control
n=161 Participants
Single Antiplatelet Therapy or No Therapy (Control): Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.
|
|---|---|---|
|
Primary Efficacy Endpoint: Ischemic Stroke or Systemic Embolism.
|
20 Participants
|
11 Participants
|
Adverse Events
WATCHMAN (Device)
Serious events: 259 serious events
Other events: 108 other events
Deaths: 105 deaths
Control
Serious events: 114 serious events
Other events: 38 other events
Deaths: 45 deaths
Serious adverse events
| Measure |
WATCHMAN (Device)
n=320 participants at risk
WATCHMAN LAAC Device implant including modified post-implant drug regimen.
|
Control
n=161 participants at risk
Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
1.9%
6/320 • Number of events 6 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Cardiac failure
|
5.9%
19/320 • Number of events 27 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
5.0%
8/161 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Cardiac failure acute
|
2.8%
9/320 • Number of events 11 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
3.1%
5/161 • Number of events 7 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Cardiac failure congestive
|
10.0%
32/320 • Number of events 43 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
11.2%
18/161 • Number of events 34 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Cardiac tamponade
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
22/320 • Number of events 28 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
4.3%
7/161 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
1.6%
5/320 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.9%
6/320 • Number of events 6 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Cardiac ventricular disorder
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Bradycardia
|
1.6%
5/320 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Splenic embolism
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Acute myocardial infarction
|
3.8%
12/320 • Number of events 13 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
5.0%
8/161 • Number of events 11 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Angina pectoris
|
5.6%
18/320 • Number of events 22 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Angina unstable
|
1.2%
4/320 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Aortic valve stenosis
|
1.6%
5/320 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
2.5%
4/161 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Atrial fibrillation
|
8.8%
28/320 • Number of events 34 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
9.9%
16/161 • Number of events 20 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Atrial flutter
|
0.94%
3/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Atrioventricular block complete
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Bifascicular block
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
2.5%
4/161 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Cardiogenic shock
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Cardiomyopathy
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Coronary artery disease
|
2.8%
9/320 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
2.5%
4/161 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Mitral valve incompetence
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
5/320 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Pericardial effusion
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Pericarditis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Sinus bradycardia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Sinus node dysfunction
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Tachycardia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Tachycardia induced cardiomyopathy
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.62%
2/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Endocrine disorders
Goitre
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Endocrine disorders
Hypothyroidism
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Eye disorders
Amaurosis fugax
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Eye disorders
Cataract
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Eye disorders
Corneal degeneration
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Eye disorders
Corneal oedema
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Ascites
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Colitis
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Constipation
|
0.62%
2/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.31%
1/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Faecaloma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.31%
1/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
10.9%
35/320 • Number of events 54 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
6.2%
10/161 • Number of events 11 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Haematemesis
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Haematochezia
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.31%
1/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Ileus
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Megacolon
|
0.31%
1/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Melaena
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Proctalgia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.2%
7/320 • Number of events 7 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.94%
3/320 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Asthenia
|
3.4%
11/320 • Number of events 12 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Catheter site haematoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Catheter site haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Chest pain
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Death
|
32.5%
104/320 • Number of events 104 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
28.0%
45/161 • Number of events 45 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Decreased activity
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Device related thrombosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Effusion
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
General physical health deterioration
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Impaired healing
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Non-cardiac chest pain
|
4.4%
14/320 • Number of events 15 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
2.5%
4/161 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Organ failure
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Pyrexia
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.2%
4/320 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Acute sinusitis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Bacteraemia
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Bacterial infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Bacteriuria
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Bronchitis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Campylobacter infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Catheter site infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Cellulitis
|
1.6%
5/320 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
6.2%
10/161 • Number of events 10 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Chronic sinusitis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Clostridium difficile infection
|
0.62%
2/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Corona virus infection
|
2.5%
8/320 • Number of events 8 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Cystitis
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Device related infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Diabetic foot infection
|
0.31%
1/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Diverticulitis
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Endocarditis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Enterococcal sepsis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Epididymitis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Erysipelas
|
0.62%
2/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Escherichia infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Escherichia sepsis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Febrile infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Gastroenteritis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Gastroenteritis viral
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Genitourinary tract infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Hepatic cyst infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Herpes zoster
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Infection
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Infectious pleural effusion
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Influenza
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Metapneumovirus infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Muscle abscess
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Osteomyelitis
|
0.62%
2/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Pneumonia
|
9.4%
30/320 • Number of events 37 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
8.7%
14/161 • Number of events 21 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Pneumonia bacterial
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Pneumonia viral
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Pyelonephritis
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Respiratory tract infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Sepsis
|
6.6%
21/320 • Number of events 26 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
3.7%
6/161 • Number of events 6 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Septic shock
|
1.6%
5/320 • Number of events 6 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Urethritis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
18/320 • Number of events 31 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
5.6%
9/161 • Number of events 13 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Urosepsis
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Vestibular neuronitis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Wound infection
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Wound infection bacterial
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.31%
1/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
2.8%
9/320 • Number of events 10 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.94%
3/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.31%
1/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.5%
8/320 • Number of events 8 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.31%
1/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Mental status changes postoperative
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Musculoskeletal injury
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Transfusion-related circulatory overload
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Vascular access site complication
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.94%
3/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.31%
1/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.94%
3/320 • Number of events 6 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
6/320 • Number of events 7 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Brain oedema
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.2%
7/320 • Number of events 7 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage IV
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.62%
2/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glomus jugulare tumour
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma metastatic
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cerebellar infarction
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cerebral amyloid angiopathy
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.94%
3/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cerebrovascular accident
|
4.4%
14/320 • Number of events 14 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
3.1%
5/161 • Number of events 6 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cervical myelopathy
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cranial nerve palsies multiple
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cranial nerve paralysis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Dementia
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Dementia with Lewy bodies
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Encephalopathy
|
1.9%
6/320 • Number of events 7 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
3.1%
5/161 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Hemiplegia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.62%
2/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Hypoaesthesia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Ischaemic stroke
|
1.9%
6/320 • Number of events 6 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
3.1%
5/161 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Lacunar stroke
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.94%
3/320 • Number of events 6 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Migraine
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Neurodegenerative disorder
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Seizure
|
1.2%
4/320 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Syncope
|
3.4%
11/320 • Number of events 14 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
2.5%
4/161 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Transient ischaemic attack
|
2.8%
9/320 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
3.1%
5/161 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Vascular dementia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Product Issues
Device battery issue
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Product Issues
Device failure
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Product Issues
Device lead damage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Product Issues
Device leakage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Product Issues
Device malfunction
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Product Issues
Thrombosis in device
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Psychiatric disorders
Alcohol abuse
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Psychiatric disorders
Confusional state
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Psychiatric disorders
Mental status changes
|
2.5%
8/320 • Number of events 8 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Psychiatric disorders
Neuropsychiatric symptoms
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Psychiatric disorders
Psychogenic seizure
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Psychiatric disorders
Sleep terror
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.6%
21/320 • Number of events 27 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
7.5%
12/161 • Number of events 16 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
End stage renal disease
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Haematuria
|
2.2%
7/320 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Prerenal failure
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Renal embolism
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Renal failure
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Renal impairment
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Urinary retention
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.2%
7/320 • Number of events 7 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.5%
8/320 • Number of events 8 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
4.3%
7/161 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
3.1%
5/161 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.2%
4/320 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.6%
5/320 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.9%
6/320 • Number of events 6 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
7/320 • Number of events 8 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.4%
14/320 • Number of events 15 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
5.0%
8/161 • Number of events 10 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Social circumstances
Social problem
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Aortic aneurysm
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Aortic stenosis
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Arteriosclerosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Deep vein thrombosis
|
2.2%
7/320 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
2.5%
4/161 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Haematoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Haemorrhage
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Hypertension
|
1.6%
5/320 • Number of events 5 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Hypertensive crisis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Hypoperfusion
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Hypotension
|
2.5%
8/320 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Orthostatic hypotension
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.94%
3/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Peripheral ischaemia
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Shock
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Shock haemorrhagic
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Steal syndrome
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Subclavian artery thrombosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Thrombosis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
Other adverse events
| Measure |
WATCHMAN (Device)
n=320 participants at risk
WATCHMAN LAAC Device implant including modified post-implant drug regimen.
|
Control
n=161 participants at risk
Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.4%
14/320 • Number of events 21 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Haematoma
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Haemorrhage
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Hypertension
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Hypertensive crisis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Hypotension
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Haematemesis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Haematochezia
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Melaena
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Asthenia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Catheter site haematoma
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Catheter site haemorrhage
|
1.9%
6/320 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Device related thrombosis
|
2.2%
7/320 • Number of events 8 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Implant site haematoma
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Implant site haemorrhage
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
General disorders
Pyrexia
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Immune system disorders
Drug hypersensitivity
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Cystitis
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Pneumonia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Laceration
|
2.8%
9/320 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
1.6%
5/320 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Investigations
Haemoglobin decreased
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Investigations
Liver function test abnormal
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Aphasia
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Areflexia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cerebral haematoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cerebral microhaemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Headache
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Neurological decompensation
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Seizure
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Syncope
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.9%
3/161 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Product Issues
Device leakage
|
1.2%
4/320 • Number of events 4 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Product Issues
Thrombosis in device
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Psychiatric disorders
Mental status changes
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Haematuria
|
4.7%
15/320 • Number of events 15 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
5.6%
9/161 • Number of events 9 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Renal and urinary disorders
Urinary retention
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Reproductive system and breast disorders
Penile haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Angina pectoris
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
1.2%
2/161 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Atrial septal defect acquired
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.94%
3/320 • Number of events 3 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Pericardial effusion
|
0.62%
2/320 • Number of events 2 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Eye disorders
Visual impairment
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/320 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.62%
1/161 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.31%
1/320 • Number of events 1 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
0.00%
0/161 • The occurrence of events are collected between time of randomization and the 5 year follow-up.
|
Additional Information
Thomas Näschen, Sr. Clinical Trial Manager
Boston Scientific
Phone: +49 1707828594
Email: [email protected]
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