Trial Outcomes & Findings for Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (NCT NCT02202434)
NCT ID: NCT02202434
Last Updated: 2021-12-17
Results Overview
Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1425 participants
Primary outcome timeframe
1 year following procedure
Results posted on
2021-12-17
Participant Flow
912 subjects randomized from 22Sep2014 to 24Dec2015. 102 subjects enrolled in the Roll-in cohort. 295 subjects enrolled in the US CAS from 25Feb2016 to 23Feb2017. Enrollment in the LOTUS Edge Valve System - Single-arm Edge Nested Reg is ongoing. Enrollment in the LOTUS Edge Valve System - Single-arm 29mm Reg and Roll-in Cohorts has not begun.
The non-randomized Roll-In phase with only the test device was for centers with no previous experience implanting the Lotus Valve System. Each performed at least two Roll-In cases before starting RCT. Only cohorts that have completed enrollment, reached primary endpoint and were submitted for regulatory approval are included in the Results Section
Participant milestones
| Measure |
Lotus Valve System - Randomized
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
607
|
305
|
102
|
295
|
|
Overall Study
COMPLETED
|
498
|
236
|
87
|
258
|
|
Overall Study
NOT COMPLETED
|
109
|
69
|
15
|
37
|
Reasons for withdrawal
| Measure |
Lotus Valve System - Randomized
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Overall Study
Death
|
70
|
39
|
13
|
27
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
13
|
14
|
1
|
4
|
|
Overall Study
Completed Study
|
1
|
0
|
0
|
0
|
|
Overall Study
Visit Missed
|
21
|
12
|
0
|
5
|
|
Overall Study
Other
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
Baseline characteristics by cohort
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Total
n=1309 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Lotus Valve System - Randomized
|
82.8 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=7 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=4 Participants
|
82.8 Years
STANDARD_DEVIATION 7.1 • n=21 Participants
|
|
Age, Continuous
CoreValve TAVR System - Randomize
|
0 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
82.9 Years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=4 Participants
|
82.9 Years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
|
Age, Continuous
Lotus Valve System - Single-arm Roll-in Cohort
|
0 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=7 Participants
|
83.6 Years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=4 Participants
|
83.6 Years
STANDARD_DEVIATION 6.9 • n=21 Participants
|
|
Age, Continuous
Lotus Valve System - Single-arm Continued Access
|
0 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=7 Participants
|
0 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
81.7 Years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
81.7 Years
STANDARD_DEVIATION 6.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
304 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
652 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
303 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
657 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black, of African Heritage
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
537 Participants
n=5 Participants
|
271 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
271 Participants
n=4 Participants
|
1172 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
18 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
531 participants
n=5 Participants
|
261 participants
n=7 Participants
|
100 participants
n=5 Participants
|
295 participants
n=4 Participants
|
1187 participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
15 participants
n=5 Participants
|
8 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Region of Enrollment
France
|
23 participants
n=5 Participants
|
13 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
36 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
33 participants
n=5 Participants
|
20 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
53 participants
n=21 Participants
|
|
Society of Thoracic Surgeons (STS) Risk Score
Lotus Valve System - Randomized
|
6.7 Percent
STANDARD_DEVIATION 4.0 • n=5 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=7 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=4 Participants
|
6.7 Percent
STANDARD_DEVIATION 4.0 • n=21 Participants
|
|
Society of Thoracic Surgeons (STS) Risk Score
CoreValve TAVR System - Randomized
|
0 Percent
STANDARD_DEVIATION 0 • n=5 Participants
|
6.9 Percent
STANDARD_DEVIATION 4.1 • n=7 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=4 Participants
|
6.9 Percent
STANDARD_DEVIATION 4.1 • n=21 Participants
|
|
Society of Thoracic Surgeons (STS) Risk Score
Lotus Valve System - Single-arm Roll-in Cohort
|
0 Percent
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=7 Participants
|
7.0 Percent
STANDARD_DEVIATION 4.9 • n=5 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=4 Participants
|
7.0 Percent
STANDARD_DEVIATION 4.9 • n=21 Participants
|
|
Society of Thoracic Surgeons (STS) Risk Score
Lotus Valve System - Single-arm Continued Access
|
0 Percent
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=7 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=5 Participants
|
5.4 Percent
STANDARD_DEVIATION 2.9 • n=4 Participants
|
5.4 Percent
STANDARD_DEVIATION 2.9 • n=21 Participants
|
|
European System for Cardiac Operative Risk Evaluation (EuroSCORE)
Lotus Valve System - Randomized
|
6.4 Percent
STANDARD_DEVIATION 5.5 • n=5 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=7 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=4 Participants
|
6.4 Percent
STANDARD_DEVIATION 5.5 • n=21 Participants
|
|
European System for Cardiac Operative Risk Evaluation (EuroSCORE)
CoreValve TAVR System - Randomized
|
0 Percent
STANDARD_DEVIATION 0 • n=5 Participants
|
6.4 Percent
STANDARD_DEVIATION 5.5 • n=7 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=4 Participants
|
6.4 Percent
STANDARD_DEVIATION 5.5 • n=21 Participants
|
|
European System for Cardiac Operative Risk Evaluation (EuroSCORE)
Lotus Valve System - Single-arm Roll-in Cohort
|
0 Percent
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=7 Participants
|
6.4 Percent
STANDARD_DEVIATION 6.5 • n=5 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=4 Participants
|
6.4 Percent
STANDARD_DEVIATION 6.5 • n=21 Participants
|
|
European System for Cardiac Operative Risk Evaluation (EuroSCORE)
Lotus Valve System - Single-arm Continued Access
|
0 Percent
STANDARD_DEVIATION 0 • n=5 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=7 Participants
|
0 Percent
STANDARD_DEVIATION 0 • n=5 Participants
|
5.3 Percent
STANDARD_DEVIATION 5.9 • n=4 Participants
|
5.3 Percent
STANDARD_DEVIATION 5.9 • n=21 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA II
|
174 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
402 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA III
|
386 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
171 Participants
n=4 Participants
|
813 Participants
n=21 Participants
|
|
New York Heart Association (NYHA) Classification
NYHA IV
|
47 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 30 days following procedurePopulation: Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.
Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=577 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=297 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Events Included in the Primary Safety Endpoint
|
20.3 Percent of participants
|
17.2 Percent of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 year following procedurePopulation: Non-inferiority analysis - Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. Superiority analysis - Intent to Treat Population The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms.
Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment).
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Events Included in the Primary Effectiveness Endpoint
Implanted
|
15.4 Percent of Participants
|
25.5 Percent of Participants
|
—
|
—
|
|
Percentage of Participants With Events Included in the Primary Effectiveness Endpoint
Intent to Treat
|
15.8 Percent of Participants
|
26.0 Percent of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 year following procedurePopulation: ITT - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.
Moderate or greater paravalvular aortic regurgitation based on Independent echocardiographic core lab assessment performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation by Pibarot et al (J Am Coll Cardiol Img 2015: 8: 340-60). The grading scheme ranges from Trace (the least clinically significant) to severe (the most clinically significant).
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation
|
0.9 Percent of Participants
|
6.9 Percent of Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at discharge or 7 days post-procedure (whichever comes first)Population: Intent to Treat
Successful deployment of the study valve
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Successful Deployment of the Study Valve
|
97.8 Percentage of participants
|
99.0 Percentage of participants
|
99.0 Percentage of participants
|
96.6 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at discharge or 7 days post-procedure (whichever comes first)Population: Number of Intent to Treat participants who had Retrieval attempted
Successful retrieval of the study valve if retrieval is attempted
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=40 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=14 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=5 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=24 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted
|
100 Percentage of Participants
|
92.9 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at discharge or 7 days post-procedure (whichever comes first)Population: Number of Intent to Treat participants who had Repositioning attempted
Successful repositioning of the study valve if repositioning is attempted
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=197 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=35 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=46 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=140 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
97.1 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at discharge or 7 days post-procedure (whichever comes first)Population: Intent to Treat
Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined. The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Total - Trace or Greater
|
35.1 Percentage of Participants
|
73.3 Percentage of Participants
|
36.8 Percentage of Participants
|
34.7 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Total - Mild
|
15.4 Percentage of Participants
|
48.7 Percentage of Participants
|
15.8 Percentage of Participants
|
24.5 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Total - Moderate or Greater
|
0.9 Percentage of Participants
|
4.3 Percentage of Participants
|
1.1 Percentage of Participants
|
0.4 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Central - Trace or Greater
|
15.2 Percentage of Participants
|
8.7 Percentage of Participants
|
15.8 Percentage of Participants
|
15.3 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Central - None
|
84.8 Percentage of Participants
|
91.3 Percentage of Participants
|
84.2 Percentage of Participants
|
84.7 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Central - Trace/Trivial
|
6.1 Percentage of Participants
|
1.8 Percentage of Participants
|
6.3 Percentage of Participants
|
4.0 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Central - Mild
|
4.2 Percentage of Participants
|
0.7 Percentage of Participants
|
3.2 Percentage of Participants
|
4.7 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Central - Mild-Moderate
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Central - Moderate
|
0.0 Percentage of Participants
|
0.4 Percentage of Participants
|
1.1 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Central - Moderate-Severe
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Central - Severe
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Central - Moderate or Greater
|
0.0 Percentage of Participants
|
0.4 Percentage of Participants
|
1.1 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Central - AR but Severity Not Evaluable
|
4.9 Percentage of Participants
|
5.8 Percentage of Participants
|
5.3 Percentage of Participants
|
6.6 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Paravalvular - Trace or Greater
|
26.9 Percentage of Participants
|
72.6 Percentage of Participants
|
28.4 Percentage of Participants
|
28.5 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Paravalvular - None
|
73.1 Percentage of Participants
|
27.4 Percentage of Participants
|
71.6 Percentage of Participants
|
71.5 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Paravalvular - Trace/Trivial
|
10.5 Percentage of Participants
|
18.1 Percentage of Participants
|
12.6 Percentage of Participants
|
2.9 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Paravalvular - Mild
|
11.8 Percentage of Participants
|
46.9 Percentage of Participants
|
12.6 Percentage of Participants
|
18.2 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Paravalvular - Mild-Moderate
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Paravalvular - Moderate
|
0.4 Percentage of Participants
|
3.6 Percentage of Participants
|
0.0 Percentage of Participants
|
0.4 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Paravalvular - Moderate-Severe
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Paravalvular - Severe
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Paravalvular - Moderate or Greater
|
0.4 Percentage of Participants
|
3.6 Percentage of Participants
|
0.0 Percentage of Participants
|
0.4 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Paravalvular - AR but Severity Not Evaluable
|
4.3 Percentage of Participants
|
4.0 Percentage of Participants
|
3.2 Percentage of Participants
|
6.9 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Total - None
|
64.9 Percentage of Participants
|
26.7 Percentage of Participants
|
63.2 Percentage of Participants
|
65.3 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Total - Trace/Trivial
|
17.4 Percentage of Participants
|
18.4 Percentage of Participants
|
20.0 Percentage of Participants
|
8.8 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Total - Mild-Moderate
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Total - Moderate
|
0.9 Percentage of Participants
|
4.3 Percentage of Participants
|
1.1 Percentage of Participants
|
0.4 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Total - Moderate-Severe
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Total - Severe
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Total - AR but Severity Not Evaluable
|
1.4 Percentage of Participants
|
1.8 Percentage of Participants
|
0.0 Percentage of Participants
|
1.1 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post procedurePopulation: Intent to Treat
Defined as implantation of the study device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Clinical Procedural Success
|
81.4 Percentage of Participants
|
84.6 Percentage of Participants
|
81.4 Percentage of Participants
|
81.0 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post procedurePopulation: Intent to Treat
Defined as absence of procedural mortality, correct positioning of a single transcatheter valve into the proper anatomical location , intended performance of the study device (effective orifice area \[EOA\] \>0.9 cm2 for body surface area (BSA) \<1.6 m2 and EOA \>1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient \<20 mm Hg or a peak velocity \<3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) plus no serious adverse events
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Procedural Success
|
32.0 Percentage of participants
|
39.2 Percentage of participants
|
33.3 Percentage of participants
|
29.3 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, and peak aortic velocity
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1
Discharge or 7 Days - Aortic Valve Area
|
1.65 cm^2
Standard Deviation 0.47
|
1.96 cm^2
Standard Deviation 0.52
|
1.70 cm^2
Standard Deviation 0.49
|
1.61 cm^2
Standard Deviation 0.42
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1
30 Days - Aortic Valve Area
|
1.59 cm^2
Standard Deviation 0.45
|
1.98 cm^2
Standard Deviation 0.51
|
1.62 cm^2
Standard Deviation 0.46
|
1.55 cm^2
Standard Deviation 0.41
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1
6 Months - Aortic Valve Area
|
1.46 cm^2
Standard Deviation 0.46
|
1.74 cm^2
Standard Deviation 0.55
|
1.55 cm^2
Standard Deviation 0.45
|
1.56 cm^2
Standard Deviation 0.47
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1
1 Year - Aortic Valve Area
|
1.49 cm^2
Standard Deviation 0.45
|
1.69 cm^2
Standard Deviation 0.52
|
1.53 cm^2
Standard Deviation 0.49
|
1.51 cm^2
Standard Deviation 0.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Assessed by an independent core laboratory - mean and peak aortic gradients
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2
6 Months - Mean Aortic Valve Gradient
|
11.93 mmHg
Standard Deviation 5.21
|
7.89 mmHg
Standard Deviation 4.24
|
12.33 mmHg
Standard Deviation 5.89
|
12.20 mmHg
Standard Deviation 5.42
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2
6 Months - Peak Aortic Gradient
|
22.24 mmHg
Standard Deviation 9.82
|
14.84 mmHg
Standard Deviation 7.46
|
22.85 mmHg
Standard Deviation 10.60
|
22.68 mmHg
Standard Deviation 9.81
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2
1 Year - Mean Aortic Valve Gradient
|
12.29 mmHg
Standard Deviation 5.83
|
7.89 mmHg
Standard Deviation 3.48
|
12.30 mmHg
Standard Deviation 7.39
|
12.68 mmHg
Standard Deviation 5.62
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2
1 Year - Peak Aortic Gradient
|
22.74 mmHg
Standard Deviation 10.53
|
15.22 mmHg
Standard Deviation 6.44
|
22.03 mmHg
Standard Deviation 12.05
|
23.75 mmHg
Standard Deviation 9.83
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2
Discharge or 7 Days - Mean Aortic Valve Gradient
|
12.20 mmHg
Standard Deviation 5.21
|
8.19 mmHg
Standard Deviation 3.98
|
12.13 mmHg
Standard Deviation 5.13
|
12.50 mmHg
Standard Deviation 6.01
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2
Discharge or 7 Days - Peak Aortic Gradient
|
22.28 mmHg
Standard Deviation 10.23
|
15.21 mmHg
Standard Deviation 7.20
|
21.58 mmHg
Standard Deviation 8.55
|
22.89 mmHg
Standard Deviation 10.91
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2
30 Days - Mean Aortic Valve Gradient
|
12.00 mmHg
Standard Deviation 6.08
|
7.25 mmHg
Standard Deviation 3.44
|
12.76 mmHg
Standard Deviation 8.24
|
12.24 mmHg
Standard Deviation 6.73
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2
30 Days - Peak Aortic Gradient
|
21.46 mmHg
Standard Deviation 10.27
|
13.59 mmHg
Standard Deviation 6.21
|
23.02 mmHg
Standard Deviation 13.43
|
22.56 mmHg
Standard Deviation 11.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Assessed by an independent core laboratory - peak aortic velocity
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3
30 Days - Peak Aortic Velocity
|
2.26 m/s
Standard Deviation 0.46
|
1.80 m/s
Standard Deviation 0.40
|
2.33 m/s
Standard Deviation 0.58
|
2.31 m/s
Standard Deviation 0.53
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3
Discharge or 7 Days - Peak Aortic Velocity
|
2.30 m/s
Standard Deviation 0.48
|
1.89 m/s
Standard Deviation 0.45
|
2.28 m/s
Standard Deviation 0.44
|
2.33 m/s
Standard Deviation 0.53
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3
6 Months - Peak Aortic Velocity
|
2.30 m/s
Standard Deviation 0.46
|
1.87 m/s
Standard Deviation 0.44
|
2.32 m/s
Standard Deviation 0.49
|
2.33 m/s
Standard Deviation 0.49
|
|
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3
1 Year - Peak Aortic Velocity
|
2.33 m/s
Standard Deviation 0.51
|
1.91 m/s
Standard Deviation 0.41
|
2.28 m/s
Standard Deviation 0.55
|
2.39 m/s
Standard Deviation 0.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined. The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
1 Year Paravalvular Mild
|
11.3 Percentage of participants
|
38.8 Percentage of participants
|
14.0 Percentage of participants
|
12.3 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
30 Day Paravalvular Moderate-Severe
|
0.2 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
30 Day Paravalvular Severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
30 Day Paravalvular Moderate or Greater
|
0.6 Percentage of participants
|
7.2 Percentage of participants
|
1.0 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
30 Day Paravalvular AR but Severity not evaluable
|
5.5 Percentage of participants
|
4.9 Percentage of participants
|
4.0 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
6 Month Paravalvular - Trace or Greater
|
22.3 Percentage of participants
|
62.7 Percentage of participants
|
23.8 Percentage of participants
|
26.9 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
6 Month Paravalvular None
|
77.7 Percentage of participants
|
37.3 Percentage of participants
|
76.2 Percentage of participants
|
73.1 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
6 Month Paravalvular Trace/Trivial
|
4.2 Percentage of participants
|
6.8 Percentage of participants
|
7.1 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
6 Month Paravalvular Mild
|
11.5 Percentage of participants
|
42.4 Percentage of participants
|
14.3 Percentage of participants
|
19.8 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
6 Month Paravalvular Mild-Moderate
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
6 Month Paravalvular Moderate
|
0.4 Percentage of participants
|
4.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
6 Month Paravalvular Moderate-Severe
|
0.2 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
6 Month Paravalvular Severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
6 Month Paravalvular Moderate or Greater
|
0.6 Percentage of participants
|
4.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
6 Month Paravalvular AR but Severity not evaluable
|
5.9 Percentage of participants
|
8.9 Percentage of participants
|
2.4 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
1 Year Paravalvular - Trace or Greater
|
20.1 Percentage of participants
|
63.0 Percentage of participants
|
24.4 Percentage of participants
|
20.6 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
1 Year Paravalvular None
|
79.9 Percentage of participants
|
37.0 Percentage of participants
|
75.6 Percentage of participants
|
79.4 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
1 Year Paravalvular Trace/Trivial
|
5.7 Percentage of participants
|
10.5 Percentage of participants
|
4.7 Percentage of participants
|
3.3 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
1 Year Paravalvular Moderate
|
0.9 Percentage of participants
|
5.9 Percentage of participants
|
0.0 Percentage of participants
|
1.2 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
1 Year Paravalvular Moderate-Severe
|
0.0 Percentage of participants
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
1 Year Paravalvular Severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
1 Year Paravalvular Moderate or Greater
|
0.9 Percentage of participants
|
6.8 Percentage of participants
|
0.0 Percentage of participants
|
1.2 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
1 Year Paravalvular AR but Severity not evaluable
|
2.2 Percentage of participants
|
6.8 Percentage of participants
|
5.8 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
Discharge Paravalvular - Trace or Greater
|
26.9 Percentage of participants
|
72.6 Percentage of participants
|
28.4 Percentage of participants
|
28.5 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
Discharge Paravalvular None
|
73.1 Percentage of participants
|
27.4 Percentage of participants
|
71.6 Percentage of participants
|
71.5 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
Discharge Paravalvular Trace/Trivial
|
10.5 Percentage of participants
|
18.1 Percentage of participants
|
12.6 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
Discharge Paravalvular Mild
|
11.8 Percentage of participants
|
46.9 Percentage of participants
|
12.6 Percentage of participants
|
18.2 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
Discharge Paravalvular Mild-Moderate
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
Discharge Paravalvular Moderate
|
0.4 Percentage of participants
|
3.6 Percentage of participants
|
0.0 Percentage of participants
|
0.4 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
Discharge Paravalvular Severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
Discharge Paravalvular Moderate-Severe
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
Discharge Paravalvular Moderate or Greater
|
0.4 Percentage of participants
|
3.6 Percentage of participants
|
0.0 Percentage of participants
|
0.4 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
Discharge ParavalvularAR but Severity not evaluabl
|
4.3 Percentage of participants
|
4.0 Percentage of participants
|
3.2 Percentage of participants
|
6.9 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
30 Day Paravalvular - Trace or Greater
|
27.5 Percentage of participants
|
75.5 Percentage of participants
|
30.0 Percentage of participants
|
27.3 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
30 Day Paravalvular None
|
72.5 Percentage of participants
|
24.5 Percentage of participants
|
70.0 Percentage of participants
|
72.7 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
30 Day Paravalvular Trace/Trivial
|
10.7 Percentage of participants
|
14.7 Percentage of participants
|
10.0 Percentage of participants
|
2.5 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
30 Day Paravalvular Mild
|
10.7 Percentage of participants
|
48.7 Percentage of participants
|
15.0 Percentage of participants
|
18.5 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
30 Day Paravalvular Mild-Moderate
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
30 Day Paravalvular Moderate
|
0.4 Percentage of participants
|
7.2 Percentage of participants
|
1.0 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
1 Year Paravalvular Mild-Moderate
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at Baseline, 1 and 6 months; and 1, 3, and 5 years, at Baseline, 1 and 6 months and 1 Year reportedPopulation: Intent to Treat
SF-12 and Kansas City Cardiomyopathy - Baseline scores and changes from Baseline at 30 days, 6 months and 1 year * SF-12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Health Status as Evaluated by Quality of Life Questionnaires
Baseline SF-12 Physical Summary Score
|
31.9 Score on a scale
Standard Deviation 9.0
|
31.2 Score on a scale
Standard Deviation 8.9
|
33.8 Score on a scale
Standard Deviation 10.5
|
32.4 Score on a scale
Standard Deviation 10.0
|
|
Health Status as Evaluated by Quality of Life Questionnaires
Baseline KC Overall Summary Score
|
51.9 Score on a scale
Standard Deviation 23.5
|
50.7 Score on a scale
Standard Deviation 22.1
|
52.7 Score on a scale
Standard Deviation 24.6
|
53.5 Score on a scale
Standard Deviation 22.8
|
|
Health Status as Evaluated by Quality of Life Questionnaires
Baseline KC Clinical Summary Score
|
55.2 Score on a scale
Standard Deviation 23.3
|
54.9 Score on a scale
Standard Deviation 21.9
|
57.3 Score on a scale
Standard Deviation 23.7
|
57.6 Score on a scale
Standard Deviation 22.6
|
|
Health Status as Evaluated by Quality of Life Questionnaires
30 Day change from Baseline SF-12 Physical Summary
|
5.1 Score on a scale
Standard Deviation 10.5
|
6.0 Score on a scale
Standard Deviation 10.0
|
3.3 Score on a scale
Standard Deviation 10.5
|
4.3 Score on a scale
Standard Deviation 9.8
|
|
Health Status as Evaluated by Quality of Life Questionnaires
30 Day change from Baseline SF-12 Mental Health S
|
3.4 Score on a scale
Standard Deviation 12.5
|
2.3 Score on a scale
Standard Deviation 12.6
|
1.8 Score on a scale
Standard Deviation 11.3
|
3.2 Score on a scale
Standard Deviation 10.6
|
|
Health Status as Evaluated by Quality of Life Questionnaires
30 Day change from Baseline KC Overall Summary
|
20.9 Score on a scale
Standard Deviation 24.2
|
20.2 Score on a scale
Standard Deviation 24.0
|
17.4 Score on a scale
Standard Deviation 25.6
|
18.3 Score on a scale
Standard Deviation 23.1
|
|
Health Status as Evaluated by Quality of Life Questionnaires
30 Day change from Baseline KC Clinical Summary
|
17.4 Score on a scale
Standard Deviation 23.9
|
16.6 Score on a scale
Standard Deviation 22.9
|
15.2 Score on a scale
Standard Deviation 24.5
|
14.8 Score on a scale
Standard Deviation 22.2
|
|
Health Status as Evaluated by Quality of Life Questionnaires
6M change from Baseline SF-12 Physical Summary
|
5.8 Score on a scale
Standard Deviation 10.8
|
5.6 Score on a scale
Standard Deviation 10.1
|
3.6 Score on a scale
Standard Deviation 9.8
|
4.7 Score on a scale
Standard Deviation 10.7
|
|
Health Status as Evaluated by Quality of Life Questionnaires
6M change from Baseline SF-12 Mental Health Sum
|
3.3 Score on a scale
Standard Deviation 11.2
|
3.3 Score on a scale
Standard Deviation 12.6
|
2.8 Score on a scale
Standard Deviation 10.5
|
3.3 Score on a scale
Standard Deviation 11.6
|
|
Health Status as Evaluated by Quality of Life Questionnaires
6M change from Baseline KC Overal Summary Score
|
22.9 Score on a scale
Standard Deviation 23.8
|
22.7 Score on a scale
Standard Deviation 22.6
|
23.5 Score on a scale
Standard Deviation 25.5
|
21.2 Score on a scale
Standard Deviation 23.1
|
|
Health Status as Evaluated by Quality of Life Questionnaires
6M change from Baseline KC Clinical Summary Score
|
17.8 Score on a scale
Standard Deviation 22.7
|
17.0 Score on a scale
Standard Deviation 22.2
|
17.5 Score on a scale
Standard Deviation 24.0
|
15.9 Score on a scale
Standard Deviation 22.2
|
|
Health Status as Evaluated by Quality of Life Questionnaires
1Y change from Baseline SF-12 Physical Summary
|
4.7 Score on a scale
Standard Deviation 10.9
|
5.2 Score on a scale
Standard Deviation 10.1
|
3.0 Score on a scale
Standard Deviation 10.8
|
3.7 Score on a scale
Standard Deviation 10.6
|
|
Health Status as Evaluated by Quality of Life Questionnaires
1Y change from Baseline SF-12 Mental Health Sum
|
3.5 Score on a scale
Standard Deviation 11.5
|
3.7 Score on a scale
Standard Deviation 12.9
|
3.2 Score on a scale
Standard Deviation 12.5
|
3.0 Score on a scale
Standard Deviation 11.1
|
|
Health Status as Evaluated by Quality of Life Questionnaires
1Y change from Baseline KC Overall Summary Score
|
21.6 Score on a scale
Standard Deviation 24.4
|
21.4 Score on a scale
Standard Deviation 23.2
|
23.2 Score on a scale
Standard Deviation 26.7
|
20.0 Score on a scale
Standard Deviation 22.2
|
|
Health Status as Evaluated by Quality of Life Questionnaires
Baseline SF-12 Mental Health Summary Score
|
49.6 Score on a scale
Standard Deviation 11.6
|
49.0 Score on a scale
Standard Deviation 11.6
|
49.8 Score on a scale
Standard Deviation 11.0
|
50.0 Score on a scale
Standard Deviation 11.4
|
|
Health Status as Evaluated by Quality of Life Questionnaires
1Y change from Baseline KC Clinical Summary Score
|
16.3 Score on a scale
Standard Deviation 23.8
|
15.0 Score on a scale
Standard Deviation 21.5
|
15.6 Score on a scale
Standard Deviation 26.8
|
14.0 Score on a scale
Standard Deviation 21.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat patients with mortality or who were event free with sufficient follow-up for the applicable time point (30 days - at least 23 days of follow-up; 6 months - at least 150 days of follow-up; 1 year - at least 335 days of follow-up).
All-cause, Cardiovascular, and Non-cardiovascular
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Mortality
30 Day Non-Cardiovascular Mortality
|
0.2 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Mortality
6 Month All Cause Mortality
|
7.7 Percentage of participants
|
8.3 Percentage of participants
|
8.8 Percentage of participants
|
7.1 Percentage of participants
|
|
Percentage of Participants With Mortality
6 Month Cardiovascular Mortality
|
5.6 Percentage of participants
|
6.7 Percentage of participants
|
5.9 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of Participants With Mortality
6 Month Non-Cardiovascular Mortality
|
2.2 Percentage of participants
|
1.7 Percentage of participants
|
2.9 Percentage of participants
|
2.4 Percentage of participants
|
|
Percentage of Participants With Mortality
1 Year All Cause Mortality
|
11.9 Percentage of participants
|
13.5 Percentage of participants
|
12.9 Percentage of participants
|
9.2 Percentage of participants
|
|
Percentage of Participants With Mortality
1 Year Cardiovascular Mortality
|
7.7 Percentage of participants
|
9.8 Percentage of participants
|
7.9 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants With Mortality
1 Year Non-Cardiovascular Mortality
|
4.3 Percentage of participants
|
3.7 Percentage of participants
|
5.0 Percentage of participants
|
3.4 Percentage of participants
|
|
Percentage of Participants With Mortality
Discharge All Cause Mortality
|
1.3 Percentage of participants
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants With Mortality
Discharge Cardiovascular Mortality
|
1.3 Percentage of participants
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants With Mortality
Discharge Non-Cardiovascular Mortality
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Mortality
30 Day All Cause Mortality
|
2.5 Percentage of participants
|
2.3 Percentage of participants
|
0.0 Percentage of participants
|
3.4 Percentage of participants
|
|
Percentage of Participants With Mortality
30 Day Cardiovascular Mortality
|
2.3 Percentage of participants
|
2.3 Percentage of participants
|
0.0 Percentage of participants
|
3.4 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Disabling Stroke and Non-disabling Stroke
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Stroke
Discharge All Stroke
|
4.4 Percentage of participants
|
4.3 Percentage of participants
|
3.9 Percentage of participants
|
5.4 Percentage of participants
|
|
Percentage of Participants With Stroke
Discharge Disabling Stroke
|
1.8 Percentage of participants
|
3.3 Percentage of participants
|
3.9 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants With Stroke
1 Year Disabling Stroke
|
3.6 Percentage of participants
|
7.1 Percentage of participants
|
5.9 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants With Stroke
1 Year Non-Disabling Stroke
|
3.6 Percentage of participants
|
2.4 Percentage of participants
|
2.0 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of Participants With Stroke
Discharge Non-Disabling Stroke
|
2.6 Percentage of participants
|
1.0 Percentage of participants
|
0.0 Percentage of participants
|
1.7 Percentage of participants
|
|
Percentage of Participants With Stroke
30 Day All Stroke
|
4.8 Percentage of participants
|
4.3 Percentage of participants
|
4.9 Percentage of participants
|
6.8 Percentage of participants
|
|
Percentage of Participants With Stroke
30 Day Disabling Stroke
|
2.0 Percentage of participants
|
3.3 Percentage of participants
|
3.9 Percentage of participants
|
4.4 Percentage of participants
|
|
Percentage of Participants With Stroke
30 Day Non-Disabling Stroke
|
2.8 Percentage of participants
|
1.0 Percentage of participants
|
1.0 Percentage of participants
|
2.4 Percentage of participants
|
|
Percentage of Participants With Stroke
6 Month All Stroke
|
5.9 Percentage of participants
|
8.3 Percentage of participants
|
6.9 Percentage of participants
|
8.1 Percentage of participants
|
|
Percentage of Participants With Stroke
6 Month Disabling Stroke
|
2.7 Percentage of participants
|
6.3 Percentage of participants
|
5.9 Percentage of participants
|
5.4 Percentage of participants
|
|
Percentage of Participants With Stroke
6 Month Non-Disabling Stroke
|
3.2 Percentage of participants
|
2.0 Percentage of participants
|
1.0 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of Participants With Stroke
1 Year All Stroke
|
7.0 Percentage of participants
|
9.4 Percentage of participants
|
7.9 Percentage of participants
|
8.5 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Periprocedural (≤72 hours post index procedure) and spontaneous (\>72 hours post index procedure)
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Myocardial Infarction (MI)
Discharge Myocardial Infarction
|
0.5 Percentage of participants
|
1.6 Percentage of participants
|
2.0 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants With Myocardial Infarction (MI)
Discharge Peri-procedural MI
|
0.5 Percentage of participants
|
1.3 Percentage of participants
|
2.0 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants With Myocardial Infarction (MI)
Discharge Spontaneous MI
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Myocardial Infarction (MI)
30 Day Myocardial Infarction
|
0.7 Percentage of participants
|
1.3 Percentage of participants
|
2.0 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of Participants With Myocardial Infarction (MI)
30 Day Peri-procedural MI
|
0.5 Percentage of participants
|
1.0 Percentage of participants
|
2.0 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants With Myocardial Infarction (MI)
30 Day Spontaneous MI
|
0.2 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With Myocardial Infarction (MI)
6 Month Myocardial Infarction
|
2.0 Percentage of participants
|
3.0 Percentage of participants
|
2.9 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants With Myocardial Infarction (MI)
6 Month Peri-procedural MI
|
0.5 Percentage of participants
|
1.3 Percentage of participants
|
2.0 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants With Myocardial Infarction (MI)
6 Month Spontaneous MI
|
1.5 Percentage of participants
|
2.0 Percentage of participants
|
1.0 Percentage of participants
|
3.1 Percentage of participants
|
|
Percentage of Participants With Myocardial Infarction (MI)
1 Year Myocardial Infarction
|
3.2 Percentage of participants
|
4.4 Percentage of participants
|
5.0 Percentage of participants
|
4.4 Percentage of participants
|
|
Percentage of Participants With Myocardial Infarction (MI)
1 Year Peri-procedural MI
|
0.5 Percentage of participants
|
1.3 Percentage of participants
|
2.0 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants With Myocardial Infarction (MI)
1 Year Spontaneous MI
|
2.7 Percentage of participants
|
3.4 Percentage of participants
|
3.0 Percentage of participants
|
3.8 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Life-threatening (or disabling) and major (defined below) Life-threatening or Disabling Bleeding * Fatal bleeding (Bleeding Academic Research Consortium \[BARC\] type 5124,125) * Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) * Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) * Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units (BARC type 3b) Major Bleeding (BARC type 3a) * Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Bleeding
Discharge Bleeding
|
11.9 Percentage of participants
|
10.5 Percentage of participants
|
8.8 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants With Bleeding
Discharge Life-threatening or Disabling Bleeding
|
7.2 Percentage of participants
|
5.9 Percentage of participants
|
7.8 Percentage of participants
|
5.4 Percentage of participants
|
|
Percentage of Participants With Bleeding
Discharge Major Bleeding
|
4.6 Percentage of participants
|
4.6 Percentage of participants
|
1.0 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants With Bleeding
30 Day Bleeding
|
12.8 Percentage of participants
|
10.9 Percentage of participants
|
11.8 Percentage of participants
|
11.9 Percentage of participants
|
|
Percentage of Participants With Bleeding
30 Day Life-threatening or Disabling Bleeding
|
8.0 Percentage of participants
|
5.0 Percentage of participants
|
9.8 Percentage of participants
|
6.1 Percentage of participants
|
|
Percentage of Participants With Bleeding
30 Day Major Bleeding
|
4.8 Percentage of participants
|
5.9 Percentage of participants
|
2.0 Percentage of participants
|
5.8 Percentage of participants
|
|
Percentage of Participants With Bleeding
6 Month Bleeding
|
16.5 Percentage of participants
|
17.0 Percentage of participants
|
17.6 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Participants With Bleeding
6 Month Life-threatening or Disabling Bleeding
|
9.3 Percentage of participants
|
9.0 Percentage of participants
|
14.7 Percentage of participants
|
8.5 Percentage of participants
|
|
Percentage of Participants With Bleeding
6 Month Major Bleeding
|
7.2 Percentage of participants
|
8.0 Percentage of participants
|
2.9 Percentage of participants
|
6.8 Percentage of participants
|
|
Percentage of Participants With Bleeding
1 Year Bleeding
|
18.1 Percentage of participants
|
17.8 Percentage of participants
|
20.8 Percentage of participants
|
19.1 Percentage of participants
|
|
Percentage of Participants With Bleeding
1 Year Life-threatening or Disabling Bleeding
|
9.9 Percentage of participants
|
9.8 Percentage of participants
|
16.8 Percentage of participants
|
11.3 Percentage of participants
|
|
Percentage of Participants With Bleeding
1 Year Major Bleeding
|
8.3 Percentage of participants
|
8.4 Percentage of participants
|
5.0 Percentage of participants
|
8.9 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤7 days post index procedurePopulation: Intent to Treat
Acute kidney injury based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2 Change in serum creatinine (up to 7 days) compared to baseline: * Stage 1: Increase in serum creatinine to 150-199% (1.5-1.99 × increase compared with baseline) OR increase of ≥0.3 mg/dl (≥26.4 mmol/L) * Stage 2: Increase in serum creatinine to 200-299% (2.0-2.99 × increase compared with baseline) * Stage 3: Increase in serum creatinine to ≥300% (\>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) -OR- Based on urine output (up to 7 days): * Stage 1: \<0.5 ml/kg per hour for \>6 but \<12 hours * Stage 2: \<0.5 ml/kg per hour for \>12 but \<24 hours * Stage 3: \<0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours Note 1: Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Acute Kidney Injury
Acute Kidney Injury - Stage 2 or Stage 3
|
2.3 Percentage of participants
|
3.6 Percentage of participants
|
1.0 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants With Acute Kidney Injury
Stage 2
|
1.0 Percentage of participants
|
1.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Acute Kidney Injury
Stage 3 (including renal replacement therapy)
|
1.3 Percentage of participants
|
2.3 Percentage of participants
|
1.0 Percentage of participants
|
0.7 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Major vascular complication - including access site related and non access site related
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Major Vascular Complication
Discharge Major Vascular Complications
|
6.8 Percentage of participants
|
5.6 Percentage of participants
|
8.8 Percentage of participants
|
7.8 Percentage of participants
|
|
Percentage of Participants With Major Vascular Complication
6 Month Major Vascular Complications
|
7.6 Percentage of participants
|
5.7 Percentage of participants
|
8.8 Percentage of participants
|
8.1 Percentage of participants
|
|
Percentage of Participants With Major Vascular Complication
6 Month Access Site Related
|
5.1 Percentage of participants
|
3.7 Percentage of participants
|
6.9 Percentage of participants
|
4.4 Percentage of participants
|
|
Percentage of Participants With Major Vascular Complication
6 Month Not Access Site Related
|
2.7 Percentage of participants
|
2.0 Percentage of participants
|
2.9 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants With Major Vascular Complication
1 Year Major Vascular Complications
|
7.7 Percentage of participants
|
6.1 Percentage of participants
|
8.9 Percentage of participants
|
8.2 Percentage of participants
|
|
Percentage of Participants With Major Vascular Complication
1 Year Access Site Related
|
5.1 Percentage of participants
|
3.7 Percentage of participants
|
6.9 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants With Major Vascular Complication
1 Year Not Access Site Related
|
2.7 Percentage of participants
|
2.4 Percentage of participants
|
3.0 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants With Major Vascular Complication
Discharge Access Site Related
|
4.6 Percentage of participants
|
3.6 Percentage of participants
|
6.9 Percentage of participants
|
4.4 Percentage of participants
|
|
Percentage of Participants With Major Vascular Complication
Discharge Not Access Site Related
|
2.3 Percentage of participants
|
2.0 Percentage of participants
|
2.9 Percentage of participants
|
3.4 Percentage of participants
|
|
Percentage of Participants With Major Vascular Complication
30 Day Major Vascular Complications
|
7.0 Percentage of participants
|
5.3 Percentage of participants
|
8.8 Percentage of participants
|
7.8 Percentage of participants
|
|
Percentage of Participants With Major Vascular Complication
30 Day Access Site Related
|
4.7 Percentage of participants
|
3.3 Percentage of participants
|
6.9 Percentage of participants
|
4.4 Percentage of participants
|
|
Percentage of Participants With Major Vascular Complication
30 Day Not Access Site Related
|
2.5 Percentage of participants
|
2.0 Percentage of participants
|
2.9 Percentage of participants
|
3.4 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Repeat Procedure for Valve-related Dysfunction
Discharge Repeat proc valve-related dysfunction
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
1.0 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With Repeat Procedure for Valve-related Dysfunction
30 Day Repeat proc valve-related dysfunction
|
0.0 Percentage of participants
|
1.0 Percentage of participants
|
1.0 Percentage of participants
|
0.7 Percentage of participants
|
|
Percentage of Participants With Repeat Procedure for Valve-related Dysfunction
6 Month Repeat proc valve-related dysfunction
|
0.2 Percentage of participants
|
1.7 Percentage of participants
|
1.0 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of Participants With Repeat Procedure for Valve-related Dysfunction
1 Year Repeat proc valve-related dysfunction
|
0.2 Percentage of participants
|
2.0 Percentage of participants
|
1.0 Percentage of participants
|
1.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Hear Association \[NYHA\] class III or IV)
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure
Discharge
|
0.8 Percentage of participants
|
0.7 Percentage of participants
|
1.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure
30 Day
|
1.7 Percentage of participants
|
3.0 Percentage of participants
|
4.9 Percentage of participants
|
2.4 Percentage of participants
|
|
Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure
6 Month
|
6.7 Percentage of participants
|
9.3 Percentage of participants
|
9.8 Percentage of participants
|
6.4 Percentage of participants
|
|
Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure
1 Year
|
11.2 Percentage of participants
|
13.8 Percentage of participants
|
13.9 Percentage of participants
|
9.6 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
New permanent pacemaker implantation resulting from new or worsened conduction disturbances
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With New Permanent Pacemaker Implantation
Discharge
|
28.2 Percentage of participants
|
14.8 Percentage of participants
|
27.5 Percentage of participants
|
24.1 Percentage of participants
|
|
Percentage of Participants With New Permanent Pacemaker Implantation
30 Day
|
29.1 Percentage of participants
|
15.8 Percentage of participants
|
28.4 Percentage of participants
|
28.1 Percentage of participants
|
|
Percentage of Participants With New Permanent Pacemaker Implantation
6 Month
|
33.3 Percentage of participants
|
18.0 Percentage of participants
|
29.4 Percentage of participants
|
30.2 Percentage of participants
|
|
Percentage of Participants With New Permanent Pacemaker Implantation
1 Year
|
34.2 Percentage of participants
|
18.5 Percentage of participants
|
30.7 Percentage of participants
|
31.1 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
New onset of atrial fibrillation or atrial flutter
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter
Discharge
|
6.4 Percentage of participants
|
3.9 Percentage of participants
|
4.9 Percentage of participants
|
5.1 Percentage of participants
|
|
Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter
30 Day
|
5.8 Percentage of participants
|
4.3 Percentage of participants
|
5.9 Percentage of participants
|
5.1 Percentage of participants
|
|
Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter
6 Month
|
6.6 Percentage of participants
|
4.7 Percentage of participants
|
5.9 Percentage of participants
|
5.1 Percentage of participants
|
|
Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter
1 Year
|
6.6 Percentage of participants
|
4.7 Percentage of participants
|
5.9 Percentage of participants
|
5.1 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤72 hours post index procedurePopulation: Intent to Treat
Coronary obstruction
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Coronary Obstruction
|
0.2 Percentage of participants
|
0.7 Percentage of participants
|
1.0 Percentage of participants
|
0.7 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤72 hours post index procedurePopulation: Intent to Treat
Ventricular septal perforation
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Ventricular Septal Perforation
|
0.2 Percentage of participant
|
0.0 Percentage of participant
|
0.0 Percentage of participant
|
0.0 Percentage of participant
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤72 hours post index procedurePopulation: Intent to Treat
Mitral apparatus damage
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Mitral Apparatus Damage
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤72 hours post index procedurePopulation: Intent to Treat
Cardiac tamponade
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Cardiac Tamponade
|
2.5 Percentage of participants
|
1.3 Percentage of participants
|
2.0 Percentage of participants
|
1.4 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
Discharge Prosthetic aortic valve malpositioning
|
0.0 Percentage of participants
|
2.6 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
Discharge Valve Migration
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
Discharge Valve Embolization
|
0.0 Percentage of participants
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
Discharge Ectopic Valve Deployment (Procedural)
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
30 Day Valve Migration
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
6 Month Prosthetic aortic valve malpositioning
|
0.0 Percentage of participants
|
2.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
6 Month Valve Migration
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
6 Month Valve Embolization
|
0.0 Percentage of participants
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
6 Month Ectopic Valve Deployment (Procedural)
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
1 Year Prosthetic aortic valve malpositioning
|
0.0 Percentage of participants
|
2.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
1 Year Valve Migration
|
0.0 Percentage of participants
|
0.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
1 Year Valve Embolization
|
0.0 Percentage of participants
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
1 Year Ectopic Valve Deployment (Procedural)
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
30 Day Prosthetic aortic valve malpositioning
|
0.0 Percentage of participants
|
2.6 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
30 Day Valve Embolization
|
0.0 Percentage of participants
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
30 Day Ectopic Valve Deployment (Procedural)
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Prosthetic aortic valve thrombosis
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Prosthetic Aortic Valve Thrombosis
Discharge
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Thrombosis
30 Day
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
1.0 Percentage of participants
|
1.4 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Thrombosis
6 Month
|
1.2 Percentage of participants
|
0.0 Percentage of participants
|
3.9 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Thrombosis
1 Year
|
1.5 Percentage of participants
|
0.0 Percentage of participants
|
6.9 Percentage of participants
|
2.4 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.Population: Intent to Treat
Prosthetic aortic valve endocarditis
Outcome measures
| Measure |
Lotus Valve System - Randomized
n=607 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 Participants
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Continued Access Cohort
n=295 Participants
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Percentage of Participants With Prosthetic Aortic Valve Endocarditis
Discharge
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Endocarditis
30 Day
|
0.2 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Endocarditis
6 Month
|
0.5 Percentage of participants
|
0.0 Percentage of participants
|
3.9 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With Prosthetic Aortic Valve Endocarditis
1 Year
|
0.7 Percentage of participants
|
0.0 Percentage of participants
|
4.0 Percentage of participants
|
0.3 Percentage of participants
|
Adverse Events
Lotus Valve System - Single-arm Continued Access Cohort
Serious events: 229 serious events
Other events: 228 other events
Deaths: 27 deaths
Lotus Valve System - Randomized
Serious events: 431 serious events
Other events: 458 other events
Deaths: 70 deaths
CoreValve TAVR System - Randomized
Serious events: 207 serious events
Other events: 210 other events
Deaths: 40 deaths
Lotus Valve System - Single-arm Roll-in Cohort
Serious events: 72 serious events
Other events: 83 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Lotus Valve System - Single-arm Continued Access Cohort
n=295 participants at risk
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Randomized
n=607 participants at risk
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 participants at risk
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 participants at risk
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Ear and labyrinth disorders
Deafness
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.99%
6/607 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Renal failure acute
|
3.1%
9/295 • Number of events 10 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.3%
32/607 • Number of events 33 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.9%
15/305 • Number of events 15 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.9%
5/102 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Ventricular asystole
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Congenital, familial and genetic disorders
Peutz-Jeghers syndrome
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
8/295 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.4%
27/607 • Number of events 27 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.6%
5/305 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.9%
4/102 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
2.0%
6/295 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
8/607 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.0%
9/305 • Number of events 9 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
9/295 • Number of events 9 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.82%
5/607 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.9%
3/102 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Atrioventricular block complete
|
21.0%
62/295 • Number of events 62 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
22.2%
135/607 • Number of events 135 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
12.1%
37/305 • Number of events 37 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
18.6%
19/102 • Number of events 19 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Cardiac failure congestive
|
7.8%
23/295 • Number of events 24 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
10.2%
62/607 • Number of events 75 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
12.5%
38/305 • Number of events 54 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
10.8%
11/102 • Number of events 14 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Atrial fibrillation
|
5.8%
17/295 • Number of events 20 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.6%
28/607 • Number of events 28 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.3%
7/305 • Number of events 7 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.9%
6/102 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Bundle branch block left
|
5.1%
15/295 • Number of events 15 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.6%
22/607 • Number of events 22 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.0%
9/305 • Number of events 9 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
7.8%
8/102 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Cardiac arrest
|
2.4%
7/295 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.6%
16/607 • Number of events 16 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.9%
3/102 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Cardiac failure
|
1.4%
4/295 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.1%
13/607 • Number of events 15 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.3%
7/305 • Number of events 7 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Atrioventricular block
|
1.7%
5/295 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.3%
14/607 • Number of events 14 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.0%
9/305 • Number of events 9 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
6.9%
7/102 • Number of events 7 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Acute myocardial infarction
|
3.7%
11/295 • Number of events 11 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
12/607 • Number of events 13 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.6%
8/305 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Conduction disorder
|
1.7%
5/295 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
12/607 • Number of events 12 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.6%
8/305 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Bradycardia
|
2.4%
7/295 • Number of events 7 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.5%
9/607 • Number of events 9 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
4/295 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.5%
9/607 • Number of events 9 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.6%
5/305 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Atrioventricular block second degree
|
2.4%
7/295 • Number of events 7 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
8/607 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
8/607 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Angina pectoris
|
1.4%
4/295 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.99%
6/607 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.6%
8/305 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Cardiac tamponade
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.82%
5/607 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Cardiac failure chronic
|
1.4%
4/295 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
4/607 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
4/295 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
4/607 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.9%
3/102 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Ventricular fibrillation
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
2/102 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Angina unstable
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Cardiac valve disease
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Cardiac failure acute
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
2/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Atrial flutter
|
0.68%
2/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Pericarditis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Nodal rhythm
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Mitral perforation
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Electromechanical dissociation
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Bundle branch block right
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Myocardial rupture
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Aortic valve stenosis
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.6%
5/305 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Sinus arrest
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Coronary artery disease
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Aortic valve disease
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
2/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Arrhythmia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Atrial tachycardia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Atrial thrombosis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Mitral valve calcification
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Mitral valve disease
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Trifascicular block
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Eye disorders
Cataract
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Eye disorders
Vision blurred
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
3.4%
10/295 • Number of events 11 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
12/607 • Number of events 12 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.0%
9/305 • Number of events 9 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.9%
5/102 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.82%
5/607 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Ileus
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Melaena
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Colitis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Diverticulum oesophageal
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Haematochezia
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Nausea
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Gastrointestinal disorders
Volvulus
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Death
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
2/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Fatigue
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Catheter site haemorrhage
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
8/607 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Non-cardiac chest pain
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.2%
7/607 • Number of events 7 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Asthenia
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.82%
5/607 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.9%
4/102 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
General physical health deterioration
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Chest pain
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Catheter site necrosis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Catheter site haematoma
|
2.7%
8/295 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
2/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Pain
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Catheter site related reaction
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Catheter site pain
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Pyrexia
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Oedema peripheral
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Implant site haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Implant site haematoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Impaired healing
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Hernia obstructive
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Multi-organ failure
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Mechanical complication of implant
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Pneumonia
|
5.1%
15/295 • Number of events 16 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.8%
23/607 • Number of events 25 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.3%
13/305 • Number of events 14 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.9%
4/102 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Sepsis
|
2.4%
7/295 • Number of events 7 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.0%
18/607 • Number of events 18 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.6%
5/305 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
9/295 • Number of events 11 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.6%
10/607 • Number of events 10 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.0%
9/305 • Number of events 9 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.9%
4/102 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Septic shock
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.99%
6/607 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Cellulitis
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.82%
5/607 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.9%
4/102 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
4/607 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Endocarditis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
4/607 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
2/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Urosepsis
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.9%
3/102 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Catheter site infection
|
0.34%
1/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Bacteraemia
|
1.4%
4/295 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Wound infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Device related infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Viral labyrinthitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Cystitis klebsiella
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Cystitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Gangrene
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Abdominal abscess
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Catheter sepsis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Ear infection
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Haemophilus infection
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Infected sebaceous cyst
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Influenza
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Pseudomonas infection
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Pyelonephritis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
4.7%
14/295 • Number of events 14 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.3%
26/607 • Number of events 26 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.2%
16/305 • Number of events 16 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.9%
3/102 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
12/607 • Number of events 12 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Fall
|
1.7%
5/295 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
8/607 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.6%
5/305 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.99%
6/607 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.82%
5/607 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
2/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
4/607 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.9%
3/102 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Lead dislodgement
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Device failure
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Pacemaker complication
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Frostbite
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Post procedural stroke
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Device lead damage
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Urinary bladder rupture
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Echocardiogram abnormal
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
White blood cell count increased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Urine cytology abnormal
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Troponin increased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Occult blood positive
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Blood pressure systolic decreased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Blood pressure diastolic decreased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Blood culture positive
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Troponin I increased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Sinus rhythm
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Pulse absent
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Blood pressure increased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Clostridium difficile toxin test positive
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
International normalised ratio abnormal
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Oxygen saturation decreased
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Pedal pulse decreased
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Troponin T increased
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.99%
6/607 • Number of events 7 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Gout
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
4/607 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
2/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.7%
5/295 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral neoplasm benign
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Cerebrovascular accident
|
4.7%
14/295 • Number of events 14 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.5%
21/607 • Number of events 21 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
6.6%
20/305 • Number of events 20 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.9%
5/102 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Psychiatric disorders
Polydipsia psychogenic
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Syncope
|
1.4%
4/295 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.1%
13/607 • Number of events 13 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.3%
7/305 • Number of events 9 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Transient ischaemic attack
|
2.0%
6/295 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
8/607 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Embolic stroke
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
4/607 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Ischaemic stroke
|
1.7%
5/295 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Dementia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Encephalopathy
|
1.7%
5/295 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Dizziness
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Presyncope
|
0.68%
2/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Chorea
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Convulsion
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Brain stem syndrome
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Cerebellar infarction
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Headache
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Hypoxic encephalopathy
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Loss of consciousness
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Neuralgia
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Visual field defect
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Psychiatric disorders
Delirium
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.82%
5/607 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Psychiatric disorders
Mental status changes
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
2/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Orthostatic hypotension
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
4/607 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
2/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Haematuria
|
1.4%
4/295 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.82%
5/607 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.6%
5/305 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.9%
5/102 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Urinary retention
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
3.9%
4/102 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Renal impairment
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Reproductive system and breast disorders
Vaginal disorder
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.4%
10/295 • Number of events 11 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.6%
16/607 • Number of events 18 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.3%
7/305 • Number of events 7 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.8%
11/607 • Number of events 11 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.9%
3/102 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.6%
10/607 • Number of events 10 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
4/305 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.1%
9/295 • Number of events 9 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.5%
9/607 • Number of events 9 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.3%
13/305 • Number of events 13 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.9%
3/102 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.4%
4/295 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.99%
6/607 • Number of events 7 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.99%
6/607 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
4/295 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.99%
6/607 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
4/295 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.99%
6/607 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.4%
4/295 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.82%
5/607 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
2/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
2.0%
2/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
3/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.68%
2/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
3/295 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Social circumstances
Activities of daily living impaired
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Hypotension
|
1.7%
5/295 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
1.3%
8/607 • Number of events 8 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Femoral artery occlusion
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.82%
5/607 • Number of events 5 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
4/607 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Haematoma
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
4/607 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.34%
1/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
4/607 • Number of events 4 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Intermittent claudication
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
5/295 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.49%
3/607 • Number of events 3 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Labile blood pressure
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Arterial haemorrhage
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.66%
2/305 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
2/607 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Iliac artery thrombosis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Hypovolaemic shock
|
0.68%
2/295 • Number of events 2 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Extravasation blood
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Arteriosclerosis
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.98%
1/102 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Aortic aneurysm
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.16%
1/607 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.33%
1/305 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Shock
|
0.34%
1/295 • Number of events 1 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
Other adverse events
| Measure |
Lotus Valve System - Single-arm Continued Access Cohort
n=295 participants at risk
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Randomized
n=607 participants at risk
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
CoreValve TAVR System - Randomized
n=305 participants at risk
Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
Lotus Valve System - Single-arm Roll-in Cohort
n=102 participants at risk
Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
22.7%
67/295 • Number of events 69 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
24.1%
146/607 • Number of events 149 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
13.8%
42/305 • Number of events 43 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
25.5%
26/102 • Number of events 26 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.6%
49/295 • Number of events 51 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
14.2%
86/607 • Number of events 88 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
16.4%
50/305 • Number of events 56 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
12.7%
13/102 • Number of events 14 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.8%
17/295 • Number of events 17 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
6.1%
37/607 • Number of events 38 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
8.2%
25/305 • Number of events 26 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Bundle branch block left
|
34.6%
102/295 • Number of events 103 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
37.4%
227/607 • Number of events 229 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
27.2%
83/305 • Number of events 87 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
39.2%
40/102 • Number of events 40 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Atrial fibrillation
|
11.2%
33/295 • Number of events 33 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
9.6%
58/607 • Number of events 61 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
9.5%
29/305 • Number of events 30 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
10.8%
11/102 • Number of events 12 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
7.6%
46/607 • Number of events 53 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.9%
18/305 • Number of events 18 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
11.8%
12/102 • Number of events 13 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Atrioventricular block first degree
|
11.5%
34/295 • Number of events 35 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
7.2%
44/607 • Number of events 44 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
7.9%
24/305 • Number of events 24 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.9%
6/102 • Number of events 7 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.9%
6/102 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Cardiac disorders
Conduction disorder
|
5.4%
16/295 • Number of events 16 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
6.3%
38/607 • Number of events 38 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
7.2%
22/305 • Number of events 24 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Oedema peripheral
|
7.5%
22/295 • Number of events 24 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.8%
29/607 • Number of events 30 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.9%
18/305 • Number of events 20 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.4%
27/607 • Number of events 29 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
6.9%
21/305 • Number of events 22 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Urinary tract infection
|
9.5%
28/295 • Number of events 32 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
10.2%
62/607 • Number of events 66 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
11.1%
34/305 • Number of events 37 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
14.7%
15/102 • Number of events 16 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.9%
6/102 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Injury, poisoning and procedural complications
Fall
|
6.8%
20/295 • Number of events 21 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.9%
30/607 • Number of events 31 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.6%
17/305 • Number of events 18 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
10.8%
11/102 • Number of events 11 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Troponin increased
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.9%
6/102 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Investigations
Echocardiogram abnormal
|
6.1%
18/295 • Number of events 18 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.8%
35/607 • Number of events 35 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
6.2%
19/305 • Number of events 19 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.8%
29/607 • Number of events 31 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.6%
17/305 • Number of events 19 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
21/295 • Number of events 23 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
4.4%
27/607 • Number of events 29 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.9%
18/305 • Number of events 19 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Nervous system disorders
Dizziness
|
8.8%
26/295 • Number of events 28 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.9%
6/102 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Renal and urinary disorders
Renal failure acute
|
10.8%
32/295 • Number of events 33 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
9.1%
55/607 • Number of events 64 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
10.5%
32/305 • Number of events 42 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.4%
19/295 • Number of events 19 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
6.8%
41/607 • Number of events 41 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.9%
18/305 • Number of events 18 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
5.9%
6/102 • Number of events 6 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/295 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
6.9%
7/102 • Number of events 7 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
5.1%
15/295 • Number of events 16 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/607 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/305 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Hypertension
|
9.8%
29/295 • Number of events 29 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
10.0%
61/607 • Number of events 65 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
12.1%
37/305 • Number of events 37 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
0.00%
0/102 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
|
Vascular disorders
Hypotension
|
12.5%
37/295 • Number of events 39 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
9.2%
56/607 • Number of events 57 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
6.2%
19/305 • Number of events 20 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
12.7%
13/102 • Number of events 13 • 1 Year
For All Cause Mortality, the at risk population (denominator) is the ITT population who had the event or who were event free with sufficient follow-up (at least 335 days of follow-up). For the SAE/AE tables, the at risk population (denominator) is the full ITT population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER