Trial Outcomes & Findings for World-wide Randomized Antibiotic Envelope Infection Prevention Trial (NCT NCT02277990)
NCT ID: NCT02277990
Last Updated: 2019-11-05
Results Overview
CIED infections are defined as (1) superficial cellulitis in the region of the CIED pocket with wound dehiscence, erosion, or purulent drainage, (2) deep incisional or organ/space (generator pocket) surgical site infection that meets the Centers for Disease Control and Prevention criteria, independent from time of surgery, (3) persistent bacteremia, or (4) endocarditis. Major CIED infections are defined as a CIED infection resulting in one or more of the following: * CIED system removal * Any invasive procedure (e.g. pocket opened) without system removal * Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage * Death
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
7075 participants
Primary outcome timeframe
Implant to 12 months
Results posted on
2019-11-05
Participant Flow
There were 92 total patients that were enrolled into the study, but not randomized. After enrollment, but prior to randomization, 2 patients died, 31 patients were found to not meet eligibility criteria, 50 patients withdrew, 1 investigator withdrew the patient and 8 patients had an other or unknown reason for not being randomized.
Participant milestones
| Measure |
TYRX Envelope
The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
TYRX Absorbable Antibacterial Envelope
|
Control
No TYRX envelope, bare CIED
|
|---|---|---|
|
Overall Study
STARTED
|
3495
|
3488
|
|
Overall Study
COMPLETED
|
3129
|
3112
|
|
Overall Study
NOT COMPLETED
|
366
|
376
|
Reasons for withdrawal
| Measure |
TYRX Envelope
The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
TYRX Absorbable Antibacterial Envelope
|
Control
No TYRX envelope, bare CIED
|
|---|---|---|
|
Overall Study
Death
|
170
|
188
|
|
Overall Study
Withdrawal by Subject
|
64
|
53
|
|
Overall Study
Physician Decision
|
40
|
34
|
|
Overall Study
Lost to Follow-up
|
66
|
69
|
|
Overall Study
Had other reason
|
26
|
32
|
Baseline Characteristics
8 participants did not complete a baseline characteristics form
Baseline characteristics by cohort
| Measure |
TYRX Envelope
n=3495 Participants
The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
TYRX Absorbable Antibacterial Envelope
|
Control
n=3488 Participants
No TYRX envelope, bare CIED
|
Total
n=6983 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.0 years
STANDARD_DEVIATION 12.6 • n=3490 Participants • 8 participants did not complete a baseline characteristics form
|
70.1 years
STANDARD_DEVIATION 12.4 • n=3485 Participants • 8 participants did not complete a baseline characteristics form
|
70.1 years
STANDARD_DEVIATION 12.5 • n=6975 Participants • 8 participants did not complete a baseline characteristics form
|
|
Sex: Female, Male
Female
|
997 Participants
n=3495 Participants
|
976 Participants
n=3488 Participants
|
1973 Participants
n=6983 Participants
|
|
Sex: Female, Male
Male
|
2498 Participants
n=3495 Participants
|
2512 Participants
n=3488 Participants
|
5010 Participants
n=6983 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
8 Participants
n=3490 Participants • 8 participants did not complete a baseline characteristics form
|
4 Participants
n=3485 Participants • 8 participants did not complete a baseline characteristics form
|
12 Participants
n=6975 Participants • 8 participants did not complete a baseline characteristics form
|
|
Race (NIH/OMB)
Asian
|
97 Participants
n=3490 Participants • 8 participants did not complete a baseline characteristics form
|
91 Participants
n=3485 Participants • 8 participants did not complete a baseline characteristics form
|
188 Participants
n=6975 Participants • 8 participants did not complete a baseline characteristics form
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
9 Participants
n=3490 Participants • 8 participants did not complete a baseline characteristics form
|
7 Participants
n=3485 Participants • 8 participants did not complete a baseline characteristics form
|
16 Participants
n=6975 Participants • 8 participants did not complete a baseline characteristics form
|
|
Race (NIH/OMB)
Black or African American
|
202 Participants
n=3490 Participants • 8 participants did not complete a baseline characteristics form
|
207 Participants
n=3485 Participants • 8 participants did not complete a baseline characteristics form
|
409 Participants
n=6975 Participants • 8 participants did not complete a baseline characteristics form
|
|
Race (NIH/OMB)
White
|
2698 Participants
n=3490 Participants • 8 participants did not complete a baseline characteristics form
|
2691 Participants
n=3485 Participants • 8 participants did not complete a baseline characteristics form
|
5389 Participants
n=6975 Participants • 8 participants did not complete a baseline characteristics form
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3490 Participants • 8 participants did not complete a baseline characteristics form
|
0 Participants
n=3485 Participants • 8 participants did not complete a baseline characteristics form
|
0 Participants
n=6975 Participants • 8 participants did not complete a baseline characteristics form
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
476 Participants
n=3490 Participants • 8 participants did not complete a baseline characteristics form
|
485 Participants
n=3485 Participants • 8 participants did not complete a baseline characteristics form
|
961 Participants
n=6975 Participants • 8 participants did not complete a baseline characteristics form
|
|
Region of Enrollment
Singapore
|
11 participants
n=3495 Participants
|
8 participants
n=3488 Participants
|
19 participants
n=6983 Participants
|
|
Region of Enrollment
United States
|
2440 participants
n=3495 Participants
|
2441 participants
n=3488 Participants
|
4881 participants
n=6983 Participants
|
|
Region of Enrollment
Malaysia
|
42 participants
n=3495 Participants
|
41 participants
n=3488 Participants
|
83 participants
n=6983 Participants
|
|
Region of Enrollment
Portugal
|
20 participants
n=3495 Participants
|
17 participants
n=3488 Participants
|
37 participants
n=6983 Participants
|
|
Region of Enrollment
Greece
|
45 participants
n=3495 Participants
|
43 participants
n=3488 Participants
|
88 participants
n=6983 Participants
|
|
Region of Enrollment
Saudi Arabia
|
11 participants
n=3495 Participants
|
10 participants
n=3488 Participants
|
21 participants
n=6983 Participants
|
|
Region of Enrollment
Austria
|
29 participants
n=3495 Participants
|
29 participants
n=3488 Participants
|
58 participants
n=6983 Participants
|
|
Region of Enrollment
Netherlands
|
70 participants
n=3495 Participants
|
69 participants
n=3488 Participants
|
139 participants
n=6983 Participants
|
|
Region of Enrollment
Sweden
|
45 participants
n=3495 Participants
|
47 participants
n=3488 Participants
|
92 participants
n=6983 Participants
|
|
Region of Enrollment
China
|
18 participants
n=3495 Participants
|
19 participants
n=3488 Participants
|
37 participants
n=6983 Participants
|
|
Region of Enrollment
Poland
|
18 participants
n=3495 Participants
|
16 participants
n=3488 Participants
|
34 participants
n=6983 Participants
|
|
Region of Enrollment
Slovakia
|
29 participants
n=3495 Participants
|
31 participants
n=3488 Participants
|
60 participants
n=6983 Participants
|
|
Region of Enrollment
Chile
|
2 participants
n=3495 Participants
|
3 participants
n=3488 Participants
|
5 participants
n=6983 Participants
|
|
Region of Enrollment
France
|
94 participants
n=3495 Participants
|
94 participants
n=3488 Participants
|
188 participants
n=6983 Participants
|
|
Region of Enrollment
United Kingdom
|
135 participants
n=3495 Participants
|
141 participants
n=3488 Participants
|
276 participants
n=6983 Participants
|
|
Region of Enrollment
Switzerland
|
30 participants
n=3495 Participants
|
33 participants
n=3488 Participants
|
63 participants
n=6983 Participants
|
|
Region of Enrollment
Spain
|
52 participants
n=3495 Participants
|
48 participants
n=3488 Participants
|
100 participants
n=6983 Participants
|
|
Region of Enrollment
Canada
|
131 participants
n=3495 Participants
|
131 participants
n=3488 Participants
|
262 participants
n=6983 Participants
|
|
Region of Enrollment
Belgium
|
36 participants
n=3495 Participants
|
35 participants
n=3488 Participants
|
71 participants
n=6983 Participants
|
|
Region of Enrollment
Norway
|
32 participants
n=3495 Participants
|
32 participants
n=3488 Participants
|
64 participants
n=6983 Participants
|
|
Region of Enrollment
Finland
|
24 participants
n=3495 Participants
|
23 participants
n=3488 Participants
|
47 participants
n=6983 Participants
|
|
Region of Enrollment
Denmark
|
34 participants
n=3495 Participants
|
36 participants
n=3488 Participants
|
70 participants
n=6983 Participants
|
|
Region of Enrollment
Italy
|
88 participants
n=3495 Participants
|
86 participants
n=3488 Participants
|
174 participants
n=6983 Participants
|
|
Region of Enrollment
Israel
|
47 participants
n=3495 Participants
|
44 participants
n=3488 Participants
|
91 participants
n=6983 Participants
|
|
Region of Enrollment
Germany
|
12 participants
n=3495 Participants
|
11 participants
n=3488 Participants
|
23 participants
n=6983 Participants
|
PRIMARY outcome
Timeframe: Implant to 12 monthsCIED infections are defined as (1) superficial cellulitis in the region of the CIED pocket with wound dehiscence, erosion, or purulent drainage, (2) deep incisional or organ/space (generator pocket) surgical site infection that meets the Centers for Disease Control and Prevention criteria, independent from time of surgery, (3) persistent bacteremia, or (4) endocarditis. Major CIED infections are defined as a CIED infection resulting in one or more of the following: * CIED system removal * Any invasive procedure (e.g. pocket opened) without system removal * Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage * Death
Outcome measures
| Measure |
TYRX Envelope
n=3495 Participants
The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
TYRX Absorbable Antibacterial Envelope
|
Control
n=3488 Participants
No TYRX envelope, bare CIED
|
|---|---|---|
|
12 Month Kaplan-Meier Estimate of Major CIED Infection Rate
|
0.7 Percentage of subjects
Interval 0.5 to 1.1
|
1.2 Percentage of subjects
Interval 0.9 to 1.7
|
SECONDARY outcome
Timeframe: Implant to 12 monthsMajor CIED infections are defined above. Minor CIED infections are defined as CIED infections that do not meet the definition of a major CIED infection
Outcome measures
| Measure |
TYRX Envelope
n=3495 Participants
The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
TYRX Absorbable Antibacterial Envelope
|
Control
n=3488 Participants
No TYRX envelope, bare CIED
|
|---|---|---|
|
12 Month Kaplan-Meier Estimate of Major or Minor CIED Infection
|
1.4 Percentage of subjects
Interval 1.1 to 2.0
|
2.2 Percentage of subjects
Interval 1.8 to 2.8
|
SECONDARY outcome
Timeframe: Implant to 12 monthsPopulation: Per the Statistical Analysis Plan, the statistical inference for this objective was based on the As-Treated cohort instead of the Intention-to-Treat cohort. Per the cohort definition, subjects are analyzed based on the treatment (envelope or no envelope) and the device class (low or high power) that was actually received.
* A CIED system related event is defined as an adverse event related to the CIED system which includes the device, leads, implant tool(s), programmer, or TYRX envelope (if applicable) * A CIED procedure related event is defined as an adverse event that occurs due to any procedure related to the implantation or surgical modification of the system including the TYRX envelope (if applicable) * A procedure or system related complication is defined as an adverse event related to a CIED procedure or the CIED system that results in at least one of the following: Death,Termination of significant device function, Invasive intervention
Outcome measures
| Measure |
TYRX Envelope
n=3396 Participants
The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
TYRX Absorbable Antibacterial Envelope
|
Control
n=3507 Participants
No TYRX envelope, bare CIED
|
|---|---|---|
|
12 Month Kaplan-Meier Estimate of a CIED Procedure Related or System Related Complication
|
6.0 Percentage of subjects
|
6.9 Percentage of subjects
|
SECONDARY outcome
Timeframe: Throughout study follow-up Kaplan-Meier Estimate is at 36 MonthsCIED infections are defined as (1) superficial cellulitis in the region of the CIED pocket with wound dehiscence, erosion, or purulent drainage, (2) deep incisional or organ/space (generator pocket) surgical site infection that meets the Centers for Disease Control and Prevention criteria, independent from time of surgery, (3) persistent bacteremia, or (4) endocarditis. Major CIED infections are defined as a CIED infection resulting in one or more of the following: * CIED system removal * Any invasive procedure (e.g. pocket opened) without system removal * Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage * Death
Outcome measures
| Measure |
TYRX Envelope
n=3495 Participants
The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
TYRX Absorbable Antibacterial Envelope
|
Control
n=3488 Participants
No TYRX envelope, bare CIED
|
|---|---|---|
|
Kaplan-Meier Estimate of a Major Infection Throughout Follow-up
|
1.3 Percentage of subjects
Interval 0.09 to 2.0
|
1.9 Percentage of subjects
Interval 1.4 to 2.6
|
Adverse Events
TYRX Envelope
Serious events: 1553 serious events
Other events: 286 other events
Deaths: 349 deaths
Control
Serious events: 1548 serious events
Other events: 221 other events
Deaths: 365 deaths
Serious adverse events
| Measure |
TYRX Envelope
n=3495 participants at risk
The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
TYRX Absorbable Antibacterial Envelope
|
Control
n=3488 participants at risk
No TYRX envelope, bare CIED
|
|---|---|---|
|
General disorders
Chest discomfort
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Chest pain
|
0.66%
23/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.97%
34/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Complication associated with device
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Complication of device insertion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Death
|
1.1%
37/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.92%
32/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Device embolisation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Fatigue
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.29%
10/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Cardiac death
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Catheter site haematoma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Anaemia
|
0.80%
28/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.75%
26/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Anaemia folate deficiency
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.29%
10/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Acute coronary syndrome
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Acute left ventricular failure
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Acute myocardial infarction
|
0.92%
32/3495 • Assessed from baseline visit to 36-month follow-up visit
|
1.0%
35/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Angina pectoris
|
0.57%
20/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.83%
29/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Angina unstable
|
0.43%
15/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.29%
10/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Aortic valve disease
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Aortic valve incompetence
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Aortic valve stenosis
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Arrhythmia
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.23%
8/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Atrial fibrillation
|
3.6%
127/3495 • Assessed from baseline visit to 36-month follow-up visit
|
3.9%
136/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Atrial flutter
|
0.60%
21/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.52%
18/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Atrial tachycardia
|
0.17%
6/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.17%
6/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Atrial thrombosis
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
36/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.66%
23/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac asthma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac disorder
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac failure
|
3.7%
131/3495 • Assessed from baseline visit to 36-month follow-up visit
|
3.8%
131/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac failure acute
|
1.0%
35/3495 • Assessed from baseline visit to 36-month follow-up visit
|
1.4%
48/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac failure chronic
|
0.40%
14/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.75%
26/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac failure congestive
|
5.3%
186/3495 • Assessed from baseline visit to 36-month follow-up visit
|
5.7%
200/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac perforation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac tamponade
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac valve disease
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.37%
13/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.29%
10/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiogenic shock
|
0.52%
18/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.43%
15/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiomyopathy
|
0.54%
19/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.43%
15/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiomyopathy alcoholic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.17%
6/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.17%
6/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Coronary artery disease
|
0.92%
32/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.92%
32/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Coronary artery stenosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.17%
6/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.52%
18/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Left ventricular failure
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Mitral valve disease
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Mitral valve incompetence
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.32%
11/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Mitral valve stenosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Myocardial infarction
|
0.31%
11/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.29%
10/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Myocardial ischaemia
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Palpitations
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Pericardial effusion
|
0.31%
11/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Pulseless electrical activity
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Rheumatic heart disease
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Right atrial dilatation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Right ventricular failure
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Sinus node dysfunction
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.23%
8/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Tachyarrhythmia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Tachycardia
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.17%
6/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.54%
19/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.29%
10/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Ventricular fibrillation
|
0.63%
22/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.75%
26/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Ventricular tachycardia
|
2.6%
92/3495 • Assessed from baseline visit to 36-month follow-up visit
|
2.6%
92/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Congenital, familial and genetic disorders
Congenital aortic valve stenosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Congenital, familial and genetic disorders
Myotonic dystrophy
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Ear and labyrinth disorders
Otosclerosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Ear and labyrinth disorders
Vertigo
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Ear and labyrinth disorders
Vertigo labyrinthine
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Endocrine disorders
Goitre
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Endocrine disorders
Hyperparathyroidism
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Endocrine disorders
Hypothyroidism
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Endocrine disorders
Thyroid mass
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Endocrine disorders
Toxic nodular goitre
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Cataract
|
0.60%
21/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.43%
15/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Cataract nuclear
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Diplopia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Ectropion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Entropion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Exfoliation syndrome
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Eye haemorrhage
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Glaucoma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Lens dislocation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Retinal oedema
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Strabismus
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Eye disorders
Visual impairment
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Abdominal compartment syndrome
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Abdominal pain
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.26%
9/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Acute abdomen
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Anal fistula
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Ascites
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Colitis
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.17%
6/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Diverticulum
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Diverticulum oesophageal
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Dysphagia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.23%
8/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Enteritis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Enterocele
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Enterocolitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Faecaloma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Gallstone ileus
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Gastric hypomotility
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.57%
20/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.95%
33/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Haematochezia
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Ileal perforation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Ileus
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.20%
7/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.54%
19/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Melaena
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Pancreatitis
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Proctalgia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Rectal discharge
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.34%
12/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Spigelian hernia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.20%
7/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.23%
8/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Accidental death
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Adverse drug reaction
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Asthenia
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Gait disturbance
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
General physical health deterioration
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Generalised oedema
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Hernia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Impaired healing
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site bruising
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site dehiscence
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site dermatitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site discharge
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site erosion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site erythema
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site haematoma
|
0.83%
29/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.72%
25/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site haemorrhage
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site irritation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site pain
|
0.29%
10/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.49%
17/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site swelling
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Incarcerated hernia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Inflammation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Malaise
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Mass
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Medical device discomfort
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Medical device site joint pain
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Non-cardiac chest pain
|
0.37%
13/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.40%
14/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Oedema
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Oedema peripheral
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Pacemaker syndrome
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Peripheral swelling
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Phantom shocks
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Polyp
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Pyrexia
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Sudden cardiac death
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Sudden death
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Terminal state
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Ulcer
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Bile duct stone
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Biliary colic
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Hepatic mass
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Hepatitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Liver injury
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Immune system disorders
Anaphylactic reaction
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Immune system disorders
Anaphylactic shock
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Immune system disorders
Drug hypersensitivity
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Immune system disorders
Hypersensitivity
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Abdominal sepsis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Abscess
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Abscess limb
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Abscess neck
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Appendicitis
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Arthritis bacterial
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Bacteraemia
|
0.20%
7/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Biliary sepsis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Bronchitis
|
0.31%
11/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.43%
15/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Bronchitis bacterial
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Cellulitis
|
0.89%
31/3495 • Assessed from baseline visit to 36-month follow-up visit
|
1.2%
41/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Chronic sinusitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Citrobacter sepsis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Clostridium difficile colitis
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Clostridium difficile infection
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Cryptosporidiosis infection
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Cystitis
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Dengue fever
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Device related infection
|
0.17%
6/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.34%
12/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Device related sepsis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Diverticulitis
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.32%
11/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Emphysematous cholecystitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Endocarditis
|
0.17%
6/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.26%
9/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Enterobacter sepsis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Epididymitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Escherichia bacteraemia
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Gangrene
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Gastroenteritis
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Gastroenteritis viral
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Graft infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Groin abscess
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Groin infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Herpes sepsis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Herpes zoster
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Implant site cellulitis
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Implant site infection
|
0.69%
24/3495 • Assessed from baseline visit to 36-month follow-up visit
|
1.3%
44/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Incision site cellulitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Infected dermal cyst
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Infected skin ulcer
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Infection
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Influenza
|
0.54%
19/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.37%
13/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Infusion site infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Intestinal sepsis
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Kidney infection
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Labyrinthitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Lemierre syndrome
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Liver abscess
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Localised infection
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Lower respiratory tract infection
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Lung infection
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Metapneumovirus infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Neutropenic sepsis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Oesophageal candidiasis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Orchitis
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Osler's nodes
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Osteomyelitis
|
0.17%
6/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Osteomyelitis chronic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Parotitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Perirectal abscess
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pneumonia
|
3.4%
118/3495 • Assessed from baseline visit to 36-month follow-up visit
|
3.2%
112/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pneumonia bacterial
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pneumonia klebsiella
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pneumonia streptococcal
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pneumonia viral
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Post procedural infection
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Postoperative wound infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pulmonary sepsis
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.37%
13/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pyelonephritis
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pyuria
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Respiratory tract infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Retroperitoneal abscess
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Rhinovirus infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Sepsis
|
0.66%
23/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.57%
20/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Septic shock
|
0.31%
11/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.26%
9/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Staphylococcal infection
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Staphylococcal sepsis
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Stitch abscess
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Stoma site cellulitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Subcutaneous abscess
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Syphilis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Tooth infection
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Tracheostomy infection
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Upper respiratory tract infection
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Urinary tract infection
|
1.5%
52/3495 • Assessed from baseline visit to 36-month follow-up visit
|
1.6%
57/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Urosepsis
|
0.43%
15/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.49%
17/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Viral infection
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Wound infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Wound infection bacterial
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Wound infection pseudomonas
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Wound infection staphylococcal
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula maturation failure
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Back injury
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.31%
11/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.26%
9/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Cardiac vein dissection
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Cardiac vein perforation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Contusion
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Device deployment issue
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Device difficult to use
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Device use issue
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Dislocation of sternum
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Fall
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.34%
12/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Head injury
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.43%
15/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.32%
11/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Injury
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Laceration
|
0.17%
6/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Limb fracture
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Pocket erosion
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Rectal laceration postoperative
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Sacroiliac fracture
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Scar
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Sedation complication
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Skin scar contracture
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Subarachnoid haematoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.34%
12/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.32%
11/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Twiddler's syndrome
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Vascular access site dissection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Vena cava injury
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Wound
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Blood glucose decreased
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Blood potassium increased
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Blood pressure increased
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Cardiac output decreased
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Colonoscopy
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Femoral bruit
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Heart rate irregular
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Hepatic enzyme increased
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
International normalised ratio fluctuation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Platelet count decreased
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Pulse absent
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Transaminases increased
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
10/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.34%
12/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Gout
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.17%
6/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.23%
8/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Obesity
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.29%
10/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.32%
11/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.17%
6/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Facial asymmetry
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.97%
34/3495 • Assessed from baseline visit to 36-month follow-up visit
|
1.3%
46/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B precursor type acute leukaemia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.34%
12/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of prostate
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct adenocarcinoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.17%
6/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer recurrent
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage IV
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal neoplasm
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma benign
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.31%
11/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage II
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma metastatic
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteral neoplasm
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer stage 0
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Amnesia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Aphasia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Ataxia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Brain injury
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Carotid artery occlusion
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Carotid artery stenosis
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Cerebral infarction
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Cerebrovascular accident
|
0.97%
34/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.75%
26/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Dementia
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Dementia with Lewy bodies
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Dizziness
|
0.17%
6/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.23%
8/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Dysarthria
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Encephalopathy
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Headache
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Hemiparesis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Hemiplegia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Hemiplegic migraine
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Hydrocephalus
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Intracranial mass
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Intraneural cyst
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Ischaemic stroke
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.32%
11/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Lacunar infarction
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Loss of consciousness
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Migraine
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Myelomalacia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Myelopathy
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Neurodegenerative disorder
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Paraesthesia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Polyneuropathy alcoholic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Presyncope
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Restless legs syndrome
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Sciatica
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Seizure
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Seizure like phenomena
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Syncope
|
0.69%
24/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.80%
28/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Transient ischaemic attack
|
0.74%
26/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.46%
16/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Tremor
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
VIth nerve paralysis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Pregnancy, puerperium and perinatal conditions
Delivery
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device battery issue
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device breakage
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device capturing issue
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.26%
9/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device connection issue
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device dislocation
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device electrical impedance issue
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.17%
6/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device end of service
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device extrusion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device failure
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device inappropriate shock delivery
|
0.17%
6/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.32%
11/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device lead damage
|
0.54%
19/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.69%
24/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device lead issue
|
0.20%
7/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.32%
11/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device loosening
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device malfunction
|
0.29%
10/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.40%
14/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device pacing issue
|
0.46%
16/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.17%
6/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device stimulation issue
|
0.31%
11/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.57%
20/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Implant subsidence
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Lead dislodgement
|
1.1%
39/3495 • Assessed from baseline visit to 36-month follow-up visit
|
1.1%
37/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Oversensing
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.29%
10/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Thrombosis in device
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Undersensing
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Alcohol abuse
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Bipolar disorder
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Bipolar I disorder
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Delirium
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Depression
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Intentional self-injury
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Mental status changes
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.26%
9/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Suicidal behaviour
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Acute kidney injury
|
1.9%
66/3495 • Assessed from baseline visit to 36-month follow-up visit
|
2.1%
72/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Calculus bladder
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Calculus urethral
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
End stage renal disease
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Haematuria
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Hydronephrosis
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Myeloma cast nephropathy
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Nephropathy
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Pulmonary renal syndrome
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Renal aneurysm
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Renal embolism
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Renal failure
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.32%
11/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Renal haematoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Renal mass
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.17%
6/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Urethral disorder
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Urethral stenosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Urinary retention
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Prostatic haemorrhage
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Rectoprostatic fistula
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.34%
12/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.63%
22/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
45/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.92%
32/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.63%
22/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.52%
18/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haematoma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.46%
16/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.32%
11/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.20%
7/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.29%
10/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.32%
11/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.31%
11/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.17%
6/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.86%
30/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.92%
32/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal mass
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Brow ptosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Vasculitic rash
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Social circumstances
Elderly
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Social circumstances
Familial risk factor
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Argon plasma coagulation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Blepharoplasty
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Cataract operation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Heart transplant
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Hernia repair
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Jejunostomy
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Leg amputation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Metatarsal excision
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Mitral valve replacement
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Neurectomy
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Prostatectomy
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Surgical and medical procedures
Wound treatment
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Accelerated hypertension
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Aneurysm ruptured
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Aortic aneurysm
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.20%
7/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Aortic dissection
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Aortic rupture
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Aortic stenosis
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.46%
16/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Arterial disorder
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Arterial occlusive disease
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Arteriosclerosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Blood pressure fluctuation
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Brachiocephalic artery occlusion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Brachiocephalic vein occlusion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Brachiocephalic vein stenosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Deep vein thrombosis
|
0.37%
13/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.37%
13/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Haematoma
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Hypertension
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Hypertensive crisis
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Hypertensive emergency
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Hypotension
|
0.43%
15/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.46%
16/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Hypovolaemic shock
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Intermittent claudication
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Ischaemia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Lymphoedema
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Orthostatic hypotension
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.20%
7/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.17%
6/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Peripheral artery occlusion
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Peripheral embolism
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Peripheral ischaemia
|
0.26%
9/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.26%
9/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Peripheral vascular disorder
|
0.14%
5/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.17%
6/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Peripheral venous disease
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Shock haemorrhagic
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Subclavian vein occlusion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Subclavian vein stenosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Superior vena cava syndrome
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Thrombophlebitis
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Thrombosis
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Varicose vein
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Vasculitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Vena cava embolism
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Venous occlusion
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Venous stenosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Venous thrombosis limb
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
Other adverse events
| Measure |
TYRX Envelope
n=3495 participants at risk
The Medtronic TYRX Absorbable Antibacterial Envelope is an absorbable sterile prosthesis designed to hold a pacemaker pulse generator or defibrillator to create a stable environment when implanted in the body. The purpose of the absorbable coating is to act as a carrier for the antimicrobial agents.
TYRX Absorbable Antibacterial Envelope
|
Control
n=3488 participants at risk
No TYRX envelope, bare CIED
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Angina pectoris
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Atrial fibrillation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Atrioventricular block
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac discomfort
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac failure
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Cardiac failure congestive
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Intracardiac thrombus
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Palpitations
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Pericarditis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Ventricular fibrillation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Cardiac disorders
Ventricular tachycardia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Diarrhoea
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Nausea
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Pancreatitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Adverse drug reaction
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Asthenia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Chest pain
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Hernia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Impaired healing
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site bruising
|
0.20%
7/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site dehiscence
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site discharge
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site erythema
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site extravasation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site haematoma
|
1.6%
56/3495 • Assessed from baseline visit to 36-month follow-up visit
|
1.2%
43/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site haemorrhage
|
0.17%
6/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site inflammation
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site irritation
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site oedema
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site pain
|
0.66%
23/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.57%
20/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site pruritus
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site rash
|
0.17%
6/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site scar
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site swelling
|
0.37%
13/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.29%
10/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Implant site vesicles
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Medical device site laceration
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Medical device site pain
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Medical device site paraesthesia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Oedema peripheral
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Pacemaker generated arrhythmia
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Pacemaker syndrome
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Peripheral swelling
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Phantom shocks
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
General disorders
Pyrexia
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Immune system disorders
Drug hypersensitivity
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Cellulitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Device related infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Implant site cellulitis
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Implant site infection
|
0.23%
8/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.40%
14/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Infusion site cellulitis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Lower respiratory tract infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Perichondritis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Staphylococcal skin infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Stitch abscess
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Urinary tract infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Infections and infestations
Wound infection
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Cardiac vein dissection
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.14%
5/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Incision site pruritus
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Incision site vesicles
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Laceration
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Procedural anxiety
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Investigations
Blood creatinine increased
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Presyncope
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Nervous system disorders
Syncope
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device capturing issue
|
0.11%
4/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device dislocation
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device electrical finding
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device electrical impedance issue
|
0.20%
7/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device inappropriate shock delivery
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device lead damage
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device lead issue
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.09%
3/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device malfunction
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device pacing issue
|
0.20%
7/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.26%
9/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device signal detection issue
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Device stimulation issue
|
1.3%
44/3495 • Assessed from baseline visit to 36-month follow-up visit
|
1.1%
37/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Electromagnetic interference
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Lead dislodgement
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Oversensing
|
0.31%
11/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.29%
10/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Product Issues
Undersensing
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary vascular disorder
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.11%
4/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.06%
2/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Deep vein thrombosis
|
0.09%
3/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Haematoma
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Hypotension
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Jugular vein thrombosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.03%
1/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Thrombosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Venous occlusion
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Venous stenosis
|
0.03%
1/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.00%
0/3488 • Assessed from baseline visit to 36-month follow-up visit
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/3495 • Assessed from baseline visit to 36-month follow-up visit
|
0.06%
2/3488 • Assessed from baseline visit to 36-month follow-up visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In most cases, the contract allows the principal investigator to publish their data after release of a multi-center publication per the publication strategy following Medtronic's review for disclosure of confidential information ("CI"), technical correctness, disclosure of patentable or copyrightable material, and selection and order of publications by the publications committee. Any such CI and/or item identified as not technically correct is deleted prior to publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER