Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (NCT NCT03915964)
NCT ID: NCT03915964
Last Updated: 2026-06-24
Results Overview
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2659 participants
Primary outcome timeframe
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Results posted on
2026-06-24
Participant Flow
Participant milestones
| Measure |
Baricitinib 2mg
Participants received 2 milligrams (mg) of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the data monitoring committee (DMC) recommended early termination. Those with inadequate response at 1-year after start of treatment with baricitinib 2 mg could receive rescue treatment with baricitinib 4 mg.
|
Baricitinib 4mg
Participants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
|
Tumor Necrosis Factor (TNF) Inhibitor
Participants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
|
|---|---|---|---|
|
Overall Study
STARTED
|
886
|
886
|
887
|
|
Overall Study
Safety Analysis Set
|
879
|
881
|
880
|
|
Overall Study
Pooled Analysis Set
|
1219
|
1214
|
1207
|
|
Overall Study
COMPLETED
|
433
|
428
|
415
|
|
Overall Study
NOT COMPLETED
|
453
|
458
|
472
|
Reasons for withdrawal
| Measure |
Baricitinib 2mg
Participants received 2 milligrams (mg) of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the data monitoring committee (DMC) recommended early termination. Those with inadequate response at 1-year after start of treatment with baricitinib 2 mg could receive rescue treatment with baricitinib 4 mg.
|
Baricitinib 4mg
Participants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
|
Tumor Necrosis Factor (TNF) Inhibitor
Participants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
112
|
120
|
110
|
|
Overall Study
Death
|
16
|
32
|
23
|
|
Overall Study
Protocol Deviation
|
10
|
16
|
15
|
|
Overall Study
Withdrawal by Subject
|
124
|
109
|
130
|
|
Overall Study
Physician Decision
|
16
|
13
|
19
|
|
Overall Study
Lack of Efficacy
|
55
|
37
|
46
|
|
Overall Study
Pregnancy
|
0
|
2
|
3
|
|
Overall Study
Russia sites closed due to operational limitations & participants unable to attend their final visit
|
53
|
59
|
59
|
|
Overall Study
Site terminated by sponsor
|
1
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
40
|
37
|
33
|
|
Overall Study
Other
|
26
|
32
|
31
|
Baseline Characteristics
A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Baricitinib 2mg
n=879 Participants
Participants received 2 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination. Those with inadequate response at 1-year after start of treatment with baricitinib 2 mg could receive rescue treatment with baricitinib 4 mg.
|
Baricitinib 4mg
n=881 Participants
Participants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
|
TNF Inhibitor
n=880 Participants
Participants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
|
Total
n=2640 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
194 Participants
n=20 Participants
|
179 Participants
n=20 Participants
|
178 Participants
n=40 Participants
|
551 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
85 Participants
n=20 Participants
|
74 Participants
n=20 Participants
|
76 Participants
n=40 Participants
|
235 Participants
n=6 Participants
|
|
Region of Enrollment
Czechia
|
121 Participants
n=20 Participants
|
115 Participants
n=20 Participants
|
109 Participants
n=40 Participants
|
345 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
685 Participants
n=20 Participants
|
702 Participants
n=20 Participants
|
702 Participants
n=40 Participants
|
2089 Participants
n=6 Participants
|
|
Age, Continuous
|
60.10 years
STANDARD_DEVIATION 9.87 • n=20 Participants
|
59.60 years
STANDARD_DEVIATION 9.86 • n=20 Participants
|
60.50 years
STANDARD_DEVIATION 10.24 • n=40 Participants
|
60.10 years
STANDARD_DEVIATION 9.99 • n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
730 Participants
n=20 Participants
|
728 Participants
n=20 Participants
|
724 Participants
n=40 Participants
|
2182 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
64 Participants
n=20 Participants
|
79 Participants
n=20 Participants
|
80 Participants
n=40 Participants
|
223 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
16 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
26 Participants
n=40 Participants
|
58 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
89 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
804 Participants
n=20 Participants
|
802 Participants
n=20 Participants
|
813 Participants
n=40 Participants
|
2419 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
8 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
47 Participants
n=6 Participants
|
|
Region of Enrollment
Australia
|
21 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
43 Participants
n=6 Participants
|
|
Region of Enrollment
Austria
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
8 Participants
n=6 Participants
|
|
Region of Enrollment
Belgium
|
7 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
20 Participants
n=6 Participants
|
|
Region of Enrollment
Denmark
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
|
Region of Enrollment
France
|
7 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
16 Participants
n=6 Participants
|
|
Region of Enrollment
Germany
|
17 Participants
n=20 Participants
|
31 Participants
n=20 Participants
|
26 Participants
n=40 Participants
|
74 Participants
n=6 Participants
|
|
Region of Enrollment
Greece
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
17 Participants
n=6 Participants
|
|
Region of Enrollment
Hungary
|
34 Participants
n=20 Participants
|
42 Participants
n=20 Participants
|
41 Participants
n=40 Participants
|
117 Participants
n=6 Participants
|
|
Region of Enrollment
Israel
|
34 Participants
n=20 Participants
|
38 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
97 Participants
n=6 Participants
|
|
Region of Enrollment
Italy
|
10 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
24 Participants
n=6 Participants
|
|
Region of Enrollment
Lithuania
|
7 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
15 Participants
n=6 Participants
|
|
Region of Enrollment
Netherlands
|
4 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
13 Participants
n=6 Participants
|
|
Region of Enrollment
Poland
|
151 Participants
n=20 Participants
|
129 Participants
n=20 Participants
|
136 Participants
n=40 Participants
|
416 Participants
n=6 Participants
|
|
Region of Enrollment
Romania
|
43 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
117 Participants
n=6 Participants
|
|
Region of Enrollment
Russia
|
67 Participants
n=20 Participants
|
75 Participants
n=20 Participants
|
91 Participants
n=40 Participants
|
233 Participants
n=6 Participants
|
|
Region of Enrollment
Slovakia
|
13 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
48 Participants
n=6 Participants
|
|
Region of Enrollment
South Africa
|
31 Participants
n=20 Participants
|
32 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
103 Participants
n=6 Participants
|
|
Region of Enrollment
Spain
|
52 Participants
n=20 Participants
|
61 Participants
n=20 Participants
|
69 Participants
n=40 Participants
|
182 Participants
n=6 Participants
|
|
Region of Enrollment
Switzerland
|
7 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
15 Participants
n=6 Participants
|
|
Region of Enrollment
Turkey
|
6 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
15 Participants
n=6 Participants
|
|
Region of Enrollment
United Kingdom
|
13 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
46 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
225 Participants
n=20 Participants
|
223 Participants
n=20 Participants
|
224 Participants
n=40 Participants
|
672 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)Population: All participants from the pooled analysis set. As per the planned analysis, for the Baricitinib 2/4 mg arm, all events from the Baricitinib 2 mg or 4 mg arms were attributed to it, with no censoring applied after initiation of rescue treatment or any non-permitted RA treatments.
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
Outcome measures
| Measure |
Baricitinib 2mg
n=2433 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 2mg treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 4mg
n=1207 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 4mg treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
|---|---|---|---|---|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)Population: All participants from the pooled analysis set. As per the planned analysis, for the baricitinib 2 mg and 4 mg arms, events occurring after initiation of rescue treatment or any non-permitted RA treatments were censored.
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
Outcome measures
| Measure |
Baricitinib 2mg
n=1219 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 2mg treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 4mg
n=1214 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 4mg treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=1207 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
|---|---|---|---|---|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Individual Baricitinib Dose Versus TNF Inhibitor]
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
—
|
SECONDARY outcome
Timeframe: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)Population: All participants from the pooled analysis set. As per the planned analysis, for the baricitinib 2 mg and 4 mg arms, events occurring after initiation of rescue treatment or any non-permitted RA treatments were censored. For the baricitinib 2/4 mg arm, all events from the baricitinib 2 mg or 4 mg arms were attributed to it, with no censoring applied after initiation of rescue treatment or any non-permitted RA treatments.
Time from first dose of study treatment to first ATE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
Outcome measures
| Measure |
Baricitinib 2mg
n=1219 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 2mg treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 4mg
n=1214 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 4mg treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=2433 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=1207 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
|---|---|---|---|---|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
SECONDARY outcome
Timeframe: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)Population: All participants from the pooled analysis set. As per the planned analysis, for the baricitinib 2 mg and 4 mg arms, events occurring after initiation of rescue treatment or any non-permitted RA treatments were censored. For the baricitinib 2/4 mg arm, all events from the baricitinib 2 mg or 4 mg arms were attributed to it, with no censoring applied after initiation of rescue treatment or any non-permitted RA treatments.
Time from first dose of study treatment to first MACE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
Outcome measures
| Measure |
Baricitinib 2mg
n=1219 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 2mg treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 4mg
n=1214 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 4mg treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=2433 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=1207 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
|---|---|---|---|---|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
SECONDARY outcome
Timeframe: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)Population: All participants from the pooled analysis set. As per the planned analysis, for the baricitinib 2 mg and 4 mg arms, events occurring after initiation of rescue treatment or any non-permitted RA treatments were censored. For the baricitinib 2/4 mg arm, all events from the baricitinib 2 mg or 4 mg arms were attributed to it, with no censoring applied after initiation of rescue treatment or any non-permitted RA treatments.
Time from first dose of study treatment to first malignancy (excluding NMSC) was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
Outcome measures
| Measure |
Baricitinib 2mg
n=1219 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 2mg treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 4mg
n=1214 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 4mg treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=2433 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=1207 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
|---|---|---|---|---|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Malignancy (Excluding Nonmelanoma Skin Cancer [NMSC]) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
SECONDARY outcome
Timeframe: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)Population: All participants from the pooled analysis set. As per the planned analysis, for the baricitinib 2 mg and 4 mg arms, events occurring after initiation of rescue treatment or any non-permitted RA treatments were censored. For the baricitinib 2/4 mg arm, all events from the baricitinib 2 mg or 4 mg arms were attributed to it, with no censoring applied after initiation of rescue treatment or any non-permitted RA treatments.
Time from first dose of study treatment to first opportunistic infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
Outcome measures
| Measure |
Baricitinib 2mg
n=1219 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 2mg treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 4mg
n=1214 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 4mg treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=2433 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=1207 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
|---|---|---|---|---|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Opportunistic Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
SECONDARY outcome
Timeframe: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)Population: All participants from the pooled analysis set. As per the planned analysis, for the baricitinib 2 mg and 4 mg arms, events occurring after initiation of rescue treatment or any non-permitted RA treatments were censored. For the baricitinib 2/4 mg arm, all events from the baricitinib 2 mg or 4 mg arms were attributed to it, with no censoring applied after initiation of rescue treatment or any non-permitted RA treatments.
Time from first dose of study treatment to first serious infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
Outcome measures
| Measure |
Baricitinib 2mg
n=1219 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 2mg treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 4mg
n=1214 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 4mg treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=2433 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=1207 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
|---|---|---|---|---|
|
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Serious Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
NA Days
There were insufficient events to estimate the median and the 95% confidence interval.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the date of first dose of study drug up to the last dose (approximately up to 6.1 years)Population: All participants from the safety analysis set.
Duration of exposure was calculated as: * Baricitinib 2mg exposure = date of last baricitinib 2mg treatment - date of first baricitinib 2mg dose + 1. For participants who were rescued from baricitinib 2 mg to 4 mg, their drug exposure after rescue was censored and not counted as exposure to baricitinib 2mg. * Baricitinib 4mg exposure = date of last baricitinib 4mg treatment - date of first baricitinib 4mg dose + 1. * TNF inhibitor exposure = date of last TNFi (adalimumab or etanercept) - date of first TNFi dose (adalimumab or etanercept) + 1, regardless of treatment cycling from adalimumab to etanercept or vice versa. * Total baricitinib exposure (2/4 mg) = date of last baricitinib (2mg or 4mg) treatment - date of first baricitinib (2mg or 4mg) dose + 1, regardless of rescue from baricitinib 2mg to baricitinib 4mg. Patient-years is calculated as sum of duration of exposure in days for all patients in dosing regimen divided by 365.25.
Outcome measures
| Measure |
Baricitinib 2mg
n=879 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 2mg treatment arm and received at least one dose were pooled into this cohort.
|
Baricitinib 4mg
n=881 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the baricitinib 4mg treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=880 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
TNF Inhibitor
n=1760 Participants
Participants from the current study JAJA (NCT03915964) and study JAJD (NCT04086745) who were randomized to the TNF inhibitor treatment arm and received at least one dose were pooled into this cohort.
|
|---|---|---|---|---|
|
Total Duration of Treatment Exposure for Combined Baricitinib Dose, Individual Baricitinib Dose and TNF Inhibitor
|
2164.3 patient-years
|
3252.7 patient-years
|
3158.1 patient-years
|
6404.8 patient-years
|
Adverse Events
Baricitinib 2mg
Serious events: 259 serious events
Other events: 498 other events
Deaths: 16 deaths
Baricitinib 4mg
Serious events: 276 serious events
Other events: 538 other events
Deaths: 32 deaths
TNF Inhibitor
Serious events: 259 serious events
Other events: 475 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Baricitinib 2mg
n=879 participants at risk
Participants received 2 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination. Those with inadequate response at 1-year after start of treatment with baricitinib 2 mg could receive rescue treatment with baricitinib 4 mg.
|
Baricitinib 4mg
n=881 participants at risk
Participants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
|
TNF Inhibitor
n=880 participants at risk
Participants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.46%
4/879 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
1.0%
9/881 • Number of events 9 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Angina unstable
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Atrial fibrillation
|
0.68%
6/879 • Number of events 6 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.79%
7/881 • Number of events 7 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.91%
8/880 • Number of events 9 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Cardiac arrest
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Cardiac failure
|
0.46%
4/879 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Mitral valve disease mixed
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.45%
4/880 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Ear and labyrinth disorders
Endolymphatic hydrops
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Ear and labyrinth disorders
Vertigo
|
0.23%
2/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Endocrine disorders
Goitre
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 5 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Eye disorders
Uveitis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Eye disorders
Vitreous haemorrhage
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Anal fissure
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Mallory-weiss syndrome
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Mesenteric panniculitis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
General disorders
Asthenia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
General disorders
Chest pain
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
General disorders
Chills
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
General disorders
Complication associated with device
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
General disorders
Death
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.57%
5/881 • Number of events 5 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
General disorders
Drug withdrawal syndrome
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
General disorders
Non-cardiac chest pain
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 5 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
General disorders
Pain
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
General disorders
Pyrexia
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
General disorders
Sudden death
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.68%
6/880 • Number of events 6 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Abscess limb
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Appendicitis
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Arthritis bacterial
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Bacterial colitis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/685 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.14%
1/702 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.45%
4/880 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Bronchitis haemophilus
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Cellulitis
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.45%
4/881 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Covid-19
|
1.7%
15/879 • Number of events 15 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
2.0%
18/881 • Number of events 18 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
1.1%
10/880 • Number of events 11 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Covid-19 pneumonia
|
2.5%
22/879 • Number of events 22 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
2.3%
20/881 • Number of events 22 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
1.4%
12/880 • Number of events 12 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Device related infection
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Diverticulitis
|
0.68%
6/879 • Number of events 6 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.45%
4/880 • Number of events 5 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Endocarditis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Epiglottitis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Erysipelas
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Furuncle
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Gastrointestinal infection
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Genitourinary tract infection
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Hepatitis e
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Herpes zoster
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.57%
5/881 • Number of events 5 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Influenza
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Latent tuberculosis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Localised infection
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Medical device site infection
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Medical device site joint infection
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Orchitis
|
0.00%
0/194 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.56%
1/179 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/178 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Osteomyelitis
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Pericarditis tuberculous
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Pneumonia
|
1.3%
11/879 • Number of events 11 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
2.0%
18/881 • Number of events 19 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
1.6%
14/880 • Number of events 16 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Pneumonia bacterial
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Pneumonia influenzal
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Post procedural infection
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Postoperative abscess
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Postoperative wound infection
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Prostatic abscess
|
0.00%
0/194 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.56%
1/179 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/178 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Pulmonary sepsis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Pyelonephritis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Q fever
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Respiratory tract infection
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Sepsis
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.45%
4/881 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.45%
4/880 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Septic shock
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Urinary tract infection
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Vaginal abscess
|
0.00%
0/685 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.14%
1/702 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
West nile viral infection
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Fall
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.68%
6/881 • Number of events 6 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.46%
4/879 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.45%
4/881 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.80%
7/880 • Number of events 7 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Musculoskeletal foreign body
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Traumatic subarachnoid haemorrhage
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm thrombosis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Investigations
Body temperature increased
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Investigations
Muscle enzyme increased
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Metabolism and nutrition disorders
Obesity
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Finger deformity
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/881 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Joint destruction
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Joint fistula
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Joint space narrowing
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.0%
18/879 • Number of events 22 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
2.6%
23/881 • Number of events 24 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
1.2%
11/880 • Number of events 12 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.45%
4/881 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.68%
6/880 • Number of events 6 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Scapholunate dissociation
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/685 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.14%
1/702 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma malignant
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.46%
4/879 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma stage iv
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Enchondromatosis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/685 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.28%
2/702 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ependymoma benign
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone b-cell lymphoma (balt type)
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive papillary breast carcinoma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage i
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage i
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.15%
1/685 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.14%
1/702 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.15%
1/685 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neuroendocrine tumour
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phyllodes tumour
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.0%
2/194 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.56%
1/179 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
1.1%
2/178 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage i
|
0.00%
0/194 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.56%
1/179 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/178 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.52%
1/194 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/179 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/178 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer metastatic
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage i
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular seminoma (pure)
|
0.00%
0/194 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/179 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.56%
1/178 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.15%
1/685 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/685 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.14%
1/702 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Acute motor-sensory axonal neuropathy
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.11%
1/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.45%
4/880 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Cervicogenic vertigo
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Dizziness
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Headache
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Hemiparesis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.11%
1/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Intracranial haematoma
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Ischaemic stroke
|
0.46%
4/879 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.68%
6/880 • Number of events 6 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Loss of consciousness
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Myelitis transverse
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Neuromyopathy
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Sciatica
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Seizure
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Spinal stroke
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Syncope
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.68%
6/880 • Number of events 6 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Product Issues
Device dislocation
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Psychiatric disorders
Bipolar disorder
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Psychiatric disorders
Conversion disorder
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Psychiatric disorders
Depression
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Psychiatric disorders
Suicidal ideation
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Bladder tamponade
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Cystitis glandularis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.45%
4/880 • Number of events 5 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Urinary retention
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.52%
1/194 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
1.1%
2/179 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/178 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/685 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.14%
1/702 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Cystocele
|
0.15%
1/685 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.14%
1/702 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.15%
1/685 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.15%
1/685 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.29%
2/685 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Urogenital prolapse
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.15%
1/685 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.15%
1/685 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.15%
1/685 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/685 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/702 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.14%
1/702 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.79%
7/881 • Number of events 8 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.45%
4/881 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Connective tissue disease-associated interstitial lung disease
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate abnormality
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary calcification
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.91%
8/879 • Number of events 8 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
1.7%
15/881 • Number of events 15 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.68%
6/880 • Number of events 6 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Rheumatoid lung
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Skin and subcutaneous tissue disorders
Chronic cutaneous lupus erythematosus
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Surgical and medical procedures
Cardiac resynchronisation therapy
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.23%
2/879 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.34%
3/880 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Surgical and medical procedures
Nasal septal operation
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Aortic aneurysm
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
9/879 • Number of events 9 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
1.0%
9/881 • Number of events 9 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.45%
4/880 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Hypertension
|
0.34%
3/879 • Number of events 3 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.23%
2/880 • Number of events 4 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Peripheral vein thrombosis
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Thrombophlebitis
|
0.11%
1/879 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/880 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Varicose ulceration
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.00%
0/881 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/879 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/881 • Number of events 1 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
0.11%
1/880 • Number of events 2 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
Other adverse events
| Measure |
Baricitinib 2mg
n=879 participants at risk
Participants received 2 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination. Those with inadequate response at 1-year after start of treatment with baricitinib 2 mg could receive rescue treatment with baricitinib 4 mg.
|
Baricitinib 4mg
n=881 participants at risk
Participants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
|
TNF Inhibitor
n=880 participants at risk
Participants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
7.1%
62/879 • Number of events 80 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
9.5%
84/881 • Number of events 108 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
6.0%
53/880 • Number of events 67 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Covid-19
|
20.8%
183/879 • Number of events 214 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
23.3%
205/881 • Number of events 241 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
19.4%
171/880 • Number of events 192 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Herpes zoster
|
5.5%
48/879 • Number of events 52 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
7.2%
63/881 • Number of events 63 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
2.4%
21/880 • Number of events 22 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Nasopharyngitis
|
11.6%
102/879 • Number of events 174 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
13.8%
122/881 • Number of events 200 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
13.1%
115/880 • Number of events 173 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
86/879 • Number of events 117 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
10.4%
92/881 • Number of events 139 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
8.8%
77/880 • Number of events 95 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Infections and infestations
Urinary tract infection
|
11.3%
99/879 • Number of events 144 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
11.4%
100/881 • Number of events 154 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
7.6%
67/880 • Number of events 95 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.5%
31/879 • Number of events 31 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
5.3%
47/881 • Number of events 50 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
1.8%
16/880 • Number of events 16 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
47/879 • Number of events 58 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
4.2%
37/881 • Number of events 44 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
5.3%
47/880 • Number of events 53 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
31/879 • Number of events 31 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
5.8%
51/881 • Number of events 55 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
4.2%
37/880 • Number of events 42 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.2%
37/879 • Number of events 40 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
5.9%
52/881 • Number of events 62 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
4.8%
42/880 • Number of events 50 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
6.3%
55/879 • Number of events 78 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
6.2%
55/881 • Number of events 75 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
7.0%
62/880 • Number of events 85 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Nervous system disorders
Headache
|
5.2%
46/879 • Number of events 54 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
6.5%
57/881 • Number of events 68 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
4.7%
41/880 • Number of events 43 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
4.1%
8/194 • Number of events 8 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
5.6%
10/179 • Number of events 10 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
3.4%
6/178 • Number of events 6 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
|
Vascular disorders
Hypertension
|
8.1%
71/879 • Number of events 77 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
10.0%
88/881 • Number of events 91 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
8.4%
74/880 • Number of events 78 • From the time of the informed consent signature up to the last study visit (approximately up to 6.1 years)
* All participants from the safety analysis set were included in reporting of serious and other (not including serious) adverse events. For all-cause mortality reporting, all randomized participants in the study were included. * Gender specific events only occurring in male or female participants have had the number of participants at Risk adjusted accordingly. * As per the planned analysis, adverse events were summarised according to the randomized treatment arms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60