Trial Outcomes & Findings for Valiant Evo US Clinical Trial (NCT NCT02652949)
NCT ID: NCT02652949
Last Updated: 2024-04-09
Results Overview
MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture. Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries. Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
30 Days
Results posted on
2024-04-09
Participant Flow
100 subjects (53 US, 47 Outside US \[OUS\]), from 18 US sites and 15 OUS sites, contributed to the global cohort. The 1st subject was enrolled on 25/APRIL/2016, the 100th subject on 28/MARCH/2018.
A total of 152 subjects were consented to be reviewed for enrollment. 52 subjects were not approved for implantation, 100 subjects were approved for implantation. The 30-day primary endpoint was evaluated when 87 subjects completed 30-day follow-up.
Participant milestones
| Measure |
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysms (DTAA) and who met the inclusion and exclusion criteria.
|
|---|---|
|
48-Month Follow-up Secondary Endpoint
NOT COMPLETED
|
6
|
|
30-Day Follow-up for Primary Endpoint
STARTED
|
87
|
|
30-Day Follow-up for Primary Endpoint
COMPLETED
|
86
|
|
30-Day Follow-up for Primary Endpoint
NOT COMPLETED
|
1
|
|
30-Day Follow-up for Secondary Endpoint
STARTED
|
100
|
|
30-Day Follow-up for Secondary Endpoint
COMPLETED
|
99
|
|
30-Day Follow-up for Secondary Endpoint
NOT COMPLETED
|
1
|
|
6-Month Follow-up Secondary Endpoint
STARTED
|
99
|
|
6-Month Follow-up Secondary Endpoint
COMPLETED
|
91
|
|
6-Month Follow-up Secondary Endpoint
NOT COMPLETED
|
8
|
|
12-Month Follow-up Secondary Endpoint
STARTED
|
91
|
|
12-Month Follow-up Secondary Endpoint
COMPLETED
|
87
|
|
12-Month Follow-up Secondary Endpoint
NOT COMPLETED
|
4
|
|
24-Month Follow-up Secondary Endpoint
STARTED
|
87
|
|
24-Month Follow-up Secondary Endpoint
COMPLETED
|
52
|
|
24-Month Follow-up Secondary Endpoint
NOT COMPLETED
|
35
|
|
36-Month Follow-up Secondary Endpoint
STARTED
|
52
|
|
36-Month Follow-up Secondary Endpoint
COMPLETED
|
48
|
|
36-Month Follow-up Secondary Endpoint
NOT COMPLETED
|
4
|
|
48-Month Follow-up Secondary Endpoint
STARTED
|
48
|
|
48-Month Follow-up Secondary Endpoint
COMPLETED
|
42
|
|
60-Month Follow-up Secondary Endpoint
STARTED
|
42
|
|
60-Month Follow-up Secondary Endpoint
COMPLETED
|
36
|
|
60-Month Follow-up Secondary Endpoint
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Endovascular Repair
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysms (DTAA) and who met the inclusion and exclusion criteria.
|
|---|---|
|
30-Day Follow-up for Primary Endpoint
Death
|
1
|
|
30-Day Follow-up for Secondary Endpoint
Death
|
1
|
|
6-Month Follow-up Secondary Endpoint
Death
|
5
|
|
6-Month Follow-up Secondary Endpoint
Withdrawal by Subject
|
2
|
|
6-Month Follow-up Secondary Endpoint
Lost to Follow-up
|
1
|
|
12-Month Follow-up Secondary Endpoint
Death
|
4
|
|
24-Month Follow-up Secondary Endpoint
Death
|
2
|
|
24-Month Follow-up Secondary Endpoint
Withdrawal by Subject
|
3
|
|
24-Month Follow-up Secondary Endpoint
Lost to Follow-up
|
2
|
|
24-Month Follow-up Secondary Endpoint
Subject declined reconsenting to extended follow-up out to 5 years
|
28
|
|
36-Month Follow-up Secondary Endpoint
Death
|
2
|
|
36-Month Follow-up Secondary Endpoint
Withdrawal by Subject
|
2
|
|
48-Month Follow-up Secondary Endpoint
Death
|
4
|
|
48-Month Follow-up Secondary Endpoint
Lost to Follow-up
|
1
|
|
48-Month Follow-up Secondary Endpoint
Withdrawal by Subject
|
1
|
|
60-Month Follow-up Secondary Endpoint
Death
|
5
|
|
60-Month Follow-up Secondary Endpoint
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race data were not collected in OUS per regulation
Baseline characteristics by cohort
| Measure |
Endovascular Repair
n=100 Participants
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm (DTAA) and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US \[OUS\]).
|
|---|---|
|
Age, Continuous
|
70.8 Years
STANDARD_DEVIATION 8.9 • n=100 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=100 Participants
|
|
Race/Ethnicity, Customized
Number Analyzed · White
|
42 Participants
n=53 Participants • Race data were not collected in OUS per regulation
|
|
Race/Ethnicity, Customized
Number Analyzed · Non-White
|
11 Participants
n=53 Participants • Race data were not collected in OUS per regulation
|
|
Region of Enrollment
United States
|
53 participants
n=100 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=100 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=100 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=100 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=100 Participants
|
|
Region of Enrollment
Italy
|
17 participants
n=100 Participants
|
|
Region of Enrollment
France
|
10 participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: The 30-day primary endpoint was evaluated for Pre-Market Approval (PMA) approval when 87 subjects completed 30 day follow-up.
MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture. Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries. Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test.
Outcome measures
| Measure |
Endovascular Repair
n=87 Participants
Valiant Evo Thoracic Stent Graft System: Procedure: thoracic endovascular aneurysm repair (TEVAR).
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS).
|
|---|---|
|
Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Safety and Effectiveness outcome measures between 0-30 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US \[OUS\]). Measures include: peri-operative mortality, adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, and endoleaks.
Outcome measures
| Measure |
Endovascular Repair
n=100 Participants
Valiant Evo Thoracic Stent Graft System: Procedure: thoracic endovascular aneurysm repair (TEVAR).
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS).
|
|---|---|
|
Safety and Effectiveness Outcome
Peri-Operative Mortality
|
2 Participants
|
|
Safety and Effectiveness Outcome
Adverse Events (AE)
|
72 Participants
|
|
Safety and Effectiveness Outcome
Major Adverse Events (MAE)
|
29 Participants
|
|
Safety and Effectiveness Outcome
Serious Adverse Events (SAE)
|
32 Participants
|
|
Safety and Effectiveness Outcome
Secondary Procedures
|
2 Participants
|
|
Safety and Effectiveness Outcome
Loss of Stent Graft Patency
|
0 Participants
|
|
Safety and Effectiveness Outcome
Endoleaks
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 monthPopulation: Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International Trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US). Note that 6-month follow up is not mandatory for subjects enrolled under the Valiant Evo International protocol, resulting in fewer subjects analyzed at 6 months.
Safety outcome measures between 0-183 days and Effectiveness outcome measures between 31-183 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Outcome measures
| Measure |
Endovascular Repair
n=100 Participants
Valiant Evo Thoracic Stent Graft System: Procedure: thoracic endovascular aneurysm repair (TEVAR).
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS).
|
|---|---|
|
Safety and Effectiveness Outcome
All-Cause Mortality (ACM)
|
6 Participants
|
|
Safety and Effectiveness Outcome
Aneurysm-Related Mortality (ARM)
|
3 Participants
|
|
Safety and Effectiveness Outcome
Major Device Effects (MDE)
|
2 Participants
|
|
Safety and Effectiveness Outcome
Adverse Events (AE)
|
80 Participants
|
|
Safety and Effectiveness Outcome
Major Adverse Events (MAE)
|
39 Participants
|
|
Safety and Effectiveness Outcome
Serious Adverse Events (SAE)
|
50 Participants
|
|
Safety and Effectiveness Outcome
Secondary Procedures
|
4 Participants
|
|
Safety and Effectiveness Outcome
Loss of Stent Graft Patency
|
0 Participants
|
|
Safety and Effectiveness Outcome
Endoleaks
|
3 Participants
|
|
Safety and Effectiveness Outcome
Stent Graft Migration
|
0 Participants
|
|
Safety and Effectiveness Outcome
Aneurysm Expansion >5 mm relative to 1-Month
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 MonthPopulation: Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Safety outcome measures between 0-365 days and Effectiveness outcome measures between 184-365 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Outcome measures
| Measure |
Endovascular Repair
n=100 Participants
Valiant Evo Thoracic Stent Graft System: Procedure: thoracic endovascular aneurysm repair (TEVAR).
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS).
|
|---|---|
|
Safety and Effectiveness Outcome
All-Cause Mortality (ARM)
|
10 Participants
|
|
Safety and Effectiveness Outcome
Aneurysm-Related Mortality (ARM)
|
3 Participants
|
|
Safety and Effectiveness Outcome
Major Device Effects (MDE)
|
4 Participants
|
|
Safety and Effectiveness Outcome
Adverse Events (AE)
|
82 Participants
|
|
Safety and Effectiveness Outcome
Major Adverse Events (MAE)
|
44 Participants
|
|
Safety and Effectiveness Outcome
Serious Adverse Events (SAE)
|
55 Participants
|
|
Safety and Effectiveness Outcome
Secondary Procedures
|
5 Participants
|
|
Safety and Effectiveness Outcome
Loss of Stent Graft Patency
|
0 Participants
|
|
Safety and Effectiveness Outcome
Endoleaks
|
5 Participants
|
|
Safety and Effectiveness Outcome
Stent Graft Migration
|
0 Participants
|
|
Safety and Effectiveness Outcome
Aneurysm Expansion >5 mm relative to 1-Month
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 MonthPopulation: Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Safety outcome measures between 0-730 days and Effectiveness outcome measures between 366-730 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Outcome measures
| Measure |
Endovascular Repair
n=100 Participants
Valiant Evo Thoracic Stent Graft System: Procedure: thoracic endovascular aneurysm repair (TEVAR).
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS).
|
|---|---|
|
Safety and Effectiveness Outcome
All-Cause Mortality (ACM)
|
13 Participants
|
|
Safety and Effectiveness Outcome
Aneurysm-Related Mortality (ARM)
|
3 Participants
|
|
Safety and Effectiveness Outcome
Major Device Effects (MDE)
|
5 Participants
|
|
Safety and Effectiveness Outcome
Adverse Events (AE)
|
85 Participants
|
|
Safety and Effectiveness Outcome
Major Adverse Event (MAE)
|
49 Participants
|
|
Safety and Effectiveness Outcome
Serious Adverse Event (SAE)
|
62 Participants
|
|
Safety and Effectiveness Outcome
Secondary Procedures
|
6 Participants
|
|
Safety and Effectiveness Outcome
Loss of Stent Graft Patency
|
0 Participants
|
|
Safety and Effectiveness Outcome
Endoleaks
|
2 Participants
|
|
Safety and Effectiveness Outcome
Stent Graft Migration
|
0 Participants
|
|
Safety and Effectiveness Outcome
Aneurysm Expansion >5 mm relative to 1-Month
|
4 Participants
|
SECONDARY outcome
Timeframe: 36 MonthPopulation: Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Safety outcome measures between 0-1095 days and Effectiveness outcome measures between 731-1095 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Outcome measures
| Measure |
Endovascular Repair
n=100 Participants
Valiant Evo Thoracic Stent Graft System: Procedure: thoracic endovascular aneurysm repair (TEVAR).
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS).
|
|---|---|
|
Safety and Effectiveness Outcome
All-Cause Mortality (ACM)
|
14 Participants
|
|
Safety and Effectiveness Outcome
Aneurysm-Related Mortality (ARM)
|
3 Participants
|
|
Safety and Effectiveness Outcome
Major Device Effects (MDE)
|
6 Participants
|
|
Safety and Effectiveness Outcome
Adverse Events (AE)
|
88 Participants
|
|
Safety and Effectiveness Outcome
Major Adverse Events (MAE)
|
52 Participants
|
|
Safety and Effectiveness Outcome
Serious Adverse Events (SAE)
|
66 Participants
|
|
Safety and Effectiveness Outcome
Secondary Procedures
|
6 Participants
|
|
Safety and Effectiveness Outcome
Loss of Stent Graft Patency
|
0 Participants
|
|
Safety and Effectiveness Outcome
Endoleaks
|
3 Participants
|
|
Safety and Effectiveness Outcome
Stent Graft Migration
|
1 Participants
|
|
Safety and Effectiveness Outcome
Aneurysm Expansion >5 mm relative to 1-Month
|
4 Participants
|
SECONDARY outcome
Timeframe: 48 MonthPopulation: Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Safety outcome measures between 0-1460 days and Effectiveness outcome measures between 1096-1460 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."
Outcome measures
| Measure |
Endovascular Repair
n=100 Participants
Valiant Evo Thoracic Stent Graft System: Procedure: thoracic endovascular aneurysm repair (TEVAR).
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS).
|
|---|---|
|
Safety and Effectiveness Outcome
All-Cause Mortality (ACM)
|
20 Participants
|
|
Safety and Effectiveness Outcome
Aneurysm-Related Mortality (ARM)
|
4 Participants
|
|
Safety and Effectiveness Outcome
Major Device Effects (MDE)
|
8 Participants
|
|
Safety and Effectiveness Outcome
Adverse Events (AE)
|
90 Participants
|
|
Safety and Effectiveness Outcome
Major Adverse Events (MAE)
|
55 Participants
|
|
Safety and Effectiveness Outcome
Serious Adverse Events (SAE)
|
69 Participants
|
|
Safety and Effectiveness Outcome
Secondary Procedures
|
9 Participants
|
|
Safety and Effectiveness Outcome
Loss of Stent Graft Patency
|
0 Participants
|
|
Safety and Effectiveness Outcome
Endoleaks
|
6 Participants
|
|
Safety and Effectiveness Outcome
Stent Graft Migration
|
2 Participants
|
|
Safety and Effectiveness Outcome
Aneurysm Expansion >5 mm relative to 1-Month
|
6 Participants
|
SECONDARY outcome
Timeframe: 60 MonthPopulation: Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US).
Safety and Effectiveness outcome measures between implant procedure and 60 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.
Outcome measures
| Measure |
Endovascular Repair
n=100 Participants
Valiant Evo Thoracic Stent Graft System: Procedure: thoracic endovascular aneurysm repair (TEVAR).
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS).
|
|---|---|
|
Safety and Effectiveness Outcome
All-Cause Mortality (ACM)
|
23 Participants
|
|
Safety and Effectiveness Outcome
Aneurysm-Related Mortality (ARM)
|
4 Participants
|
|
Safety and Effectiveness Outcome
Major Device Effects
|
13 Participants
|
|
Safety and Effectiveness Outcome
Adverse Events (AE)
|
93 Participants
|
|
Safety and Effectiveness Outcome
Major Adverse Events (MAE)
|
59 Participants
|
|
Safety and Effectiveness Outcome
Serious Adverse Events (SAE)
|
75 Participants
|
|
Safety and Effectiveness Outcome
Secondary Procedures
|
14 Participants
|
|
Safety and Effectiveness Outcome
Loss of Stent Graft Patency
|
0 Participants
|
|
Safety and Effectiveness Outcome
Endoleaks
|
8 Participants
|
|
Safety and Effectiveness Outcome
Stent Graft Migration
|
2 Participants
|
|
Safety and Effectiveness Outcome
Aneurysm Expansion >5 mm relative to 1-Month
|
5 Participants
|
Adverse Events
Endovascular Repair 30-Day Secondary Endpoint
Serious events: 32 serious events
Other events: 62 other events
Deaths: 2 deaths
Endovascular Repair 6-Month Secondary Endpoint
Serious events: 27 serious events
Other events: 32 other events
Deaths: 6 deaths
Endovascular Repair 12-Month Secondary Endpoint
Serious events: 22 serious events
Other events: 20 other events
Deaths: 10 deaths
Endovascular Repair 24-Month Secondary Endpoint
Serious events: 17 serious events
Other events: 21 other events
Deaths: 13 deaths
Endovascular Repair 36-Month Secondary Endpoint
Serious events: 14 serious events
Other events: 14 other events
Deaths: 14 deaths
Endovascular Repair 48-Month
Serious events: 17 serious events
Other events: 16 other events
Deaths: 20 deaths
Endovascular Repair 60-Month
Serious events: 15 serious events
Other events: 14 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Endovascular Repair 30-Day Secondary Endpoint
n=100 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality, or one or more serious adverse event within 0-30 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 30-Day time period or were followed for at least 1 day.
For Adverse Events, the 30-Day time period for reporting is 0-30 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 30-Day time interval.
|
Endovascular Repair 6-Month Secondary Endpoint
n=98 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-183 days, or one or more serious adverse event within 31-183 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 6-Month time period or were followed for at least 91 days.
For Adverse Events, the 6-Month time period for reporting is 31-183 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 6-Month time interval.
|
Endovascular Repair 12-Month Secondary Endpoint
n=91 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-365 days, or one or more serious adverse event within 184-365 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 12-Month time period or were followed for at least 305 days.
For Adverse Events, the 12-Month time period for reporting is 184-365 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 12-Month time interval.
|
Endovascular Repair 24-Month Secondary Endpoint
n=84 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-730 days, or one or more serious adverse event within 366-730 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 24-Month time period or were followed for at least 549 days.
For Adverse Events, the 24-Month time period for reporting is 366-730 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 24-Month time interval.
|
Endovascular Repair 36-Month Secondary Endpoint
n=66 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1095 days, or one or more serious adverse event within 731-1095 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 36-Month time period or were followed for at least 914 days.
For Adverse Events, the 36-Month time period for reporting is 731-1095 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 36-Month time interval.
|
Endovascular Repair 48-Month
n=62 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1460 days, or one or more serious adverse event within 1096-1460 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 48-Month time period or were followed for at least 1279 days.
For Adverse Events, the 48-Month time period for reporting is 1096-1460 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 48-Month time interval.
|
Endovascular Repair 60-Month
n=49 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1825 days, or one or more serious adverse event within 1461-1825 days Procedure: thoracic endovascular aneurysm repair (TEVAR) For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 60-Month time period or were followed for at least 1644 days.
For Adverse Events, the 60-Month time period for reporting is 1461-1825 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 60-Month time interval.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Blood and lymphatic system disorders
Anaemia of Chronic Disease
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Blood and lymphatic system disorders
Neutrophilia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Blood and lymphatic system disorders
Splenic Lesion
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.4%
2/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Atrial Fibrillation
|
3.0%
3/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Atrioventricular Block
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.4%
2/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Coronary Artery Dissection
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Left Ventricular Failure
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Tachycardia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Ventricular Tachycardia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Anal Incontinence
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Change of Bowel Habit
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Colitis
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Fistula of Small Intestine
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Ileus
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Intestinal Strangulation
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Death
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Pyrexia
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Stent-Graft Endoleak
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
4.8%
3/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
6.1%
3/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Vascular Stent Thrombosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Immune system disorders
Anaphylactic Shock
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Intervertebral Discitis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Localised Infection
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
3.1%
3/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
5.5%
5/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.4%
2/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Pneumonia Aspiration
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Pulmonary Sepsis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Sepsis
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.2%
2/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Septic Shock
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Urinary Tract Infection Staphylococcal
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Urosepsis
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Vascular Device Infection
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Incomplete Spinal Fusion
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Post Lumbar Puncture Syndrome
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Postoperative Delirium
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Respiratory Tract Procedural Complication
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Tracheal Haemorrhage
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Thrombosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Investigations
Blood Creatinine Increased
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Investigations
Weight Decreased
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Pancreas
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer Recurrent
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Papillary Mucinous Neoplasm
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Stage Iii
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative Neoplasm
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Neoplasm
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Cerebellar Infarction
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.4%
2/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Dementia with Lewy Bodies
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Drug Withdrawal Convulsions
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Embolic Stroke
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Guillain-Barre Syndrome
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Hypoaesthesia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Ischaemic Stroke
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Lacunar Stroke
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Parkinson's Disease
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Spinal Cord Ischaemia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Syncope
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Vascular Encephalopathy
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Product Issues
Device Breakage
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Psychiatric disorders
Delirium Tremens
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Psychiatric disorders
Depression
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Psychiatric disorders
Mental Status Changes
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Psychiatric disorders
Suicidal Ideation
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.2%
2/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
4.1%
2/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
End Stage Renal Disease
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Ureteric Obstruction
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Urinary Bladder Polyp
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Urinary Incontinence
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
3.1%
3/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.4%
2/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
3.0%
2/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
3.6%
3/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
3.2%
2/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Aortic Dissection
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Aortic Rupture
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Atheroembolism
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Hypertension
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Hypertensive Urgency
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Iliac Artery Dissection
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Iliac Artery Stenosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Peripheral Artery Occlusion
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Peripheral Artery Thrombosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Peripheral Embolism
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Peripheral Ischaemia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Thrombophlebitis
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Complication Associated With Device
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Wound Infection
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal Cancer
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Ischaemic Cerebral Infarction
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Product Issues
Device Physical Property Issue
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Hypertensive Emergency
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
Other adverse events
| Measure |
Endovascular Repair 30-Day Secondary Endpoint
n=100 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality, or one or more serious adverse event within 0-30 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 30-Day time period or were followed for at least 1 day.
For Adverse Events, the 30-Day time period for reporting is 0-30 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 30-Day time interval.
|
Endovascular Repair 6-Month Secondary Endpoint
n=98 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-183 days, or one or more serious adverse event within 31-183 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 6-Month time period or were followed for at least 91 days.
For Adverse Events, the 6-Month time period for reporting is 31-183 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 6-Month time interval.
|
Endovascular Repair 12-Month Secondary Endpoint
n=91 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-365 days, or one or more serious adverse event within 184-365 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 12-Month time period or were followed for at least 305 days.
For Adverse Events, the 12-Month time period for reporting is 184-365 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 12-Month time interval.
|
Endovascular Repair 24-Month Secondary Endpoint
n=84 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-730 days, or one or more serious adverse event within 366-730 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 24-Month time period or were followed for at least 549 days.
For Adverse Events, the 24-Month time period for reporting is 366-730 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 24-Month time interval.
|
Endovascular Repair 36-Month Secondary Endpoint
n=66 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1095 days, or one or more serious adverse event within 731-1095 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 36-Month time period or were followed for at least 914 days.
For Adverse Events, the 36-Month time period for reporting is 731-1095 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 36-Month time interval.
|
Endovascular Repair 48-Month
n=62 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1460 days, or one or more serious adverse event within 1096-1460 days Procedure: thoracic endovascular aneurysm repair (TEVAR)
For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 48-Month time period or were followed for at least 1279 days.
For Adverse Events, the 48-Month time period for reporting is 1096-1460 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 48-Month time interval.
|
Endovascular Repair 60-Month
n=49 participants at risk
Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1825 days, or one or more serious adverse event within 1461-1825 days Procedure: thoracic endovascular aneurysm repair (TEVAR) For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 60-Month time period or were followed for at least 1644 days.
For Adverse Events, the 60-Month time period for reporting is 1461-1825 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 60-Month time interval.
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Acidosis
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Opacity
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
12.0%
12/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.4%
2/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Painful Respiration
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Blood and lymphatic system disorders
Anaemia
|
8.0%
8/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
5/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.0%
3/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Angina Pectoris
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Atrial Fibrillation
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Atrial Tachycardia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.2%
2/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Hypertensive Cardiomyopathy
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Left Ventricular Failure
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.2%
2/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Pericardial Effusion
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Sinus Bradycardia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Sinus Tachycardia
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Supraventricular Tachycardia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Torsade De Pointes
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Ventricular Extrasystoles
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Congenital, familial and genetic disorders
Atrial Septal Defect
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Congenital, familial and genetic disorders
Congenital Hypercoagulation
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Congenital, familial and genetic disorders
Gastrointestinal Arteriovenous Malformation
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Congenital, familial and genetic disorders
Loeys-Dietz Syndrome
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Ear and labyrinth disorders
Chondrodermatitis Nodularis Chronica Helicis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Ear and labyrinth disorders
Vertigo
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Eye disorders
Cataract
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Eye disorders
Visual Impairment
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Abdominal Wall Haematoma
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Constipation
|
3.0%
3/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Gastrointestinal Angiectasia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Presbyoesophagus
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Asthenia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Chest Pain
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Facial Pain
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Fatigue
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Generalised Oedema
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Influenza Like Illness
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Injury Associated With Device
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Non-Cardiac Chest Pain
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Oedema
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Oedema Peripheral
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Peripheral Swelling
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Puncture Site Haemorrhage
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Pyrexia
|
6.0%
6/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Stent-Graft Endoleak
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Central Nervous System Infection
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Covid-19
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
3.2%
2/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Epididymitis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Groin Abscess
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Influenza
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Pneumonia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
3.1%
3/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Post Procedural Sepsis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Skin Infection
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Urinary Tract Infection
|
7.0%
7/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
3.1%
3/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
3.6%
3/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Anaemia Postoperative
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Aortic Injury
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Bone Contusion
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Consolidation
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Corneal Abrasion
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Incision Site Erythema
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Periorbital Haematoma
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Post Procedural Fever
|
3.0%
3/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Postimplantation Syndrome
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Postoperative Delirium
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Postoperative Respiratory Failure
|
3.0%
3/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Procedural Site Reaction
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Seroma
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Sternal Fracture
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Complication
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haematoma
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Haemorrhage
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Investigations
Blood Magnesium Decreased
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Investigations
Oxygen Saturation Decreased
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Investigations
Troponin I Increased
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Investigations
Troponin Increased
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Investigations
Urine Output Decreased
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Gout
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.0%
5/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.4%
2/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's Disease
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Asterixis
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Carotid Artery Dissection
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Dizziness
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Headache
|
3.0%
3/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Morton's Neuralgia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Neuralgia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Neurological Decompensation
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Paraesthesia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Parkinson's Disease
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Radial Nerve Palsy
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Spinal Cord Infarction
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Spinal Subarachnoid Haemorrhage
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Psychiatric disorders
Confusional State
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Psychiatric disorders
Delirium
|
3.0%
3/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Psychiatric disorders
Depression
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.4%
2/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Psychiatric disorders
Mental Status Changes
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.0%
3/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Focal Segmental Glomerulosclerosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Haematuria
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Renal Failure
|
2.0%
2/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Renal Ischaemia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Renal Mass
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Urinary Incontinence
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Urinary Retention
|
3.0%
3/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.0%
5/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.4%
2/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic Paralysis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Skin and subcutaneous tissue disorders
Keloid Scar
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Skin and subcutaneous tissue disorders
Skin Reaction
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.4%
2/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
3.2%
2/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Aortic Dissection
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
2/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Haematoma
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Hypertension
|
7.0%
7/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
4.1%
4/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Hypotension
|
4.0%
4/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Penetrating Aortic Ulcer
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Penetrating Atherosclerotic Ulcer
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.0%
1/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.4%
2/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Peripheral Artery Haematoma
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Peripheral Embolism
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Peripheral Ischaemia
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Subclavian Artery Stenosis
|
1.0%
1/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.2%
1/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Subclavian Artery Thrombosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Blood and lymphatic system disorders
Angina Unstable
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Congenital, familial and genetic disorders
Congenital Aortic Valve Incompetence
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Ear and labyrinth disorders
Tympanic Membrane Perforation
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.1%
1/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Gastrointestinal disorders
Retroperitoneal Haematoma
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
General disorders
Impaired Self-Care
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.5%
1/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Investigations
Popliteal Pulse Increased
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Laryngeal Nerve Palsy
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
1.6%
1/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Nervous system disorders
Vocal Cord Paralysis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Bladder Hypertrophy
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Aortic Dilatation
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Subclavian Artery Dissection
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Vascular Wall Hypertrophy
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Infections and infestations
Atypical Pneumonia
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
|
Renal and urinary disorders
Renal Arteriosclerosis
|
0.00%
0/100 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/98 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/91 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/84 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/66 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
0.00%
0/62 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
2.0%
1/49 • Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months, 36 Months and 48 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Medtronic owns the data of this clinical study, a single investigation site may access and use the data provided by itself for scientific publications following prior approval by Medtronic. Pooling data from several investigation sites for publication purposes, national projects and international projects all require prior approval from Medtronic.
- Publication restrictions are in place
Restriction type: OTHER